Zachary Zubulake

PRAC Connects Cenobamate Use with Hepatic Failure Risk

A new regulatory safety communication from the European Medicines Agency's Pharmacovigilance Risk Assessment Committee is prompting labelling updates and risk characterization changes for cenobamate (Ontozry), with direct implications for regulatory affairs professionals and those overseeing post-authorization compliance.

 Following a case review, the committee agreed to issue a direct healthcare professional communication after reports of severe liver injury, including hepatic failure, in patients taking the anti-seizure medicine. Most cases occurred in patients using cenobamate alongside other anti-seizure agents. This development signals a practical reminder of how post-market surveillance data can trigger cascading documentation obligations that extend well beyond medical affairs. These changes will touch quality management systems, batch release documentation, patient information leaflets, and any materials subject to regulatory review across multiple markets. The case also illustrates that post-authorization safety data can reframe a product's risk profile in ways not fully anticipated at initial approval, making robust pharmacovigilance infrastructure and responsive documentation workflows an operational necessity rather than a compliance formality.

How Are the Recommended Monitoring Requirements Changing?

Prescribers are now advised to perform liver function tests before initiating treatment and to continue monitoring throughout its duration.

 When a patient presents with symptoms such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice, prompt clinical evaluation and liver function testing are recommended. Patients should be counseled to seek medical attention immediately if such symptoms arise.

When liver injury is suspected or confirmed, dose reduction or discontinuation should be considered.

 The guidance aligns with the existing summary of product characteristics, which already cautions against abrupt discontinuation due to the risk of rebound seizures. Elevated liver enzyme levels have been listed in the product's prescribing information as a common side effect, occurring in up to 1 in 10 patients. Following the case review, the committee recommended that liver injury be added as a rare side effect, occurring in up to 1 in 1,000 patients, along with updated warnings directed at both patients and healthcare professionals.

The direct healthcare professional communication will be forwarded to the human medicines committee for adoption.

 Once approved, it will be distributed to healthcare professionals by the marketing authorization holder according to an agreed communication plan and published in national registers across EU member states.

How Else Is the EMA Developing Drug Processes and Regulations?

A separate but equally consequential development from recent regulatory activity concerns preclinical research methodology.

On March 31, 2026, the human medicines committee issued a draft qualification opinion for a new approach that replaces standard animal control groups in dose-range finding studies with virtual control groups. The statistically derived comparators built this methodology with characterized historical control data validated through expert judgment. This signals a tangible shift in what regulators will accept as scientifically valid evidence in future medicine applications.

The immediate application is specific: dose-range finding studies in rats.

 This is just the initial step, as the committee has indicated that this qualification creates a blueprint for broader use, with potential future iterations applicable to toxicological studies for which control groups are routinely required. The cumulative reduction in animal use could be substantial.

The practical implication is that study designs incorporating virtual control groups, applied within the defined context of use, may now be submitted with a clearer path to regulatory acceptance.

 Human safety remains a non-negotiable threshold; any implementation must demonstrably avoid compromising study outcomes or downstream clinical trial safety.

Public consultation on the draft opinion runs until May 12, 2026.

 Organizations with relevant scientific expertise are encouraged to submit comments, making this an active window for industry input into a methodology that could meaningfully influence how non-clinical development is conducted across the sector.

European Medicines Agency. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2026. Published April 10, 2026. Accessed April 10, 2026. 

https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-april-2026

European Medicines Agency. EMA consults on virtual control groups to help reduce animal use in medicines development. Published March 31, 2026. Accessed April 10, 2026. 

https://www.ema.europa.eu/en/news/ema-consults-virtual-control-groups-help-reduce-animal-use-medicines-development

Articles

EMA PRAC is driving labeling and risk-characterization updates for cenobamate (Ontozry) after reports of severe liver injury, including hepatic failure, often with concomitant anti-seizure medications. Recommended risk minimization now emphasizes baseline and ongoing liver function monitoring, symptom-triggered evaluation, and consideration of dose reduction or discontinuation while avoiding abrupt withdrawal due to seizure risk. Separately, CHMP issued a draft qualification opinion supporting virtual control groups in rat dose-range finding studies, potentially reshaping nonclinical evidentiary standards and reducing animal use, with consultation open until May 12, 2026.

New PRAC safety data link cenobamate to rare severe liver injury, prompting updated monitoring requirements and revised product labeling for prescribers.

What PRAC's Flagging of Cenobamate Means for Drug Regulation

Christopher Lewis, Emoja Biopharma, explores how AI can streamline compliance, cut investigation time, and free skilled workers for higher-value tasks

How AI Is Transforming Biopharma Quality and Compliance

, Christopher Lewis, Emoja Biopharma and President of the Mountain States PDA Chapter, sat down with 

 to share his perspective on the growing role of AI in pharmaceutical quality and compliance operations.

At the heart of Lewis's viewpoint is the importance of keeping humans meaningfully involved as AI takes on a larger role. "Having human-in-the-loop at each one of those steps ensures there's a balanced approach to the risk-based model of implementing AI in the environment in which we operate," he explains.

When it comes to measuring success, Lewis points to several key metrics: investigation cycle time, hands-on labor hours, and recurrence rates for deviations and related investigations. He notes that recurrence rates might actually rise initially as AI surfaces patterns that human reviewers previously missed, a sign the tools are working, not failing. Over time, he expects those numbers to decline as root causes are more thoroughly identified and addressed.

Lewis also reflects on the presentation he moderated, showcasing real-world AI deployments in quality operations. "Companies are now putting that into use to save time, to repurpose expertise, and to really drive at increasing the quality framework," he says. What stands out to him was the shift from theoretical discussion to practical implementation, highly skilled workers being freed from repetitive tasks to focus on higher-value work. For Lewis, that transition represents a meaningful step forward for the industry.

Videos

Legacy Web Forms Put Science Organizations at Risk

The pharmaceutical and life sciences sector faces a paradox: while investing billions in cutting-edge R&D and advanced manufacturing technologies, many organizations continue collecting sensitive data through outdated web forms built without modern security protocols. These legacy systems have become critical vulnerabilities, exposing companies to data breaches, regulatory penalties, and operational disruptions that ultimately compromise research integrity and intellectual property protection.

The numbers tell a stark story. An analysis of 

 between January and late September 2025 confirms that the pharmaceutical sector is dominated by data-centric cybercrime, with ransomware accounting for 29.1% of all attacks and data breaches representing 26.7%.

 According to 2025 reporting, pharmaceutical data breaches average 

—well above the $4.44M global average reported by IBM.

 have intensified, with one-third of organizations experiencing breaches facing penalties, and the share paying fines exceeding $100,000 increasing by 19.5% year over year.

How Do Firms Secure Best Secure Their Data?

Legacy web forms used for clinical trial recruitment, adverse event reporting, laboratory data collection, and regulatory submissions frequently lack the security infrastructure required under FDA 21 CFR Part 11, GDPR, and GxP regulations. These aren't suggestions—they're mandates with substantial penalties for non-compliance.

Consider 21 CFR Part 11, which establishes requirements for electronic records and signatures in life sciences.

 The regulation requires systems to generate 

 that independently record who created, modified, or deleted data, complete with timestamps and reasons for changes. Legacy forms typically cannot provide this functionality, forcing organizations to maintain inadequate paper-based logbooks as alternatives.

Without automated, tamper-proof audit trails, pharmaceutical companies cannot demonstrate data integrity according to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).

 have specifically cited firms where "there is no assurance that your systems have appropriate controls to record all modifications to data."

GDPR presents equally serious challenges for pharmaceutical companies conducting clinical trials internationally or operating across multiple jurisdictions.

Personal data, genetic information, and health records collected through web forms must be encrypted during transmission and storage.

Yet many legacy systems transmit data over 

 or 4% of global annual revenue. For organizations operating internationally, data sovereignty violations can result in operational bans in entire countries.

Is the Industry Vulnerable to Cyber Attacks?

The pharmaceutical sector has become a prime target for cybercriminals, and legacy web forms represent particularly vulnerable entry points.

 These systems are susceptible to SQL injection and cross-site scripting attacks—two of the most prevalent web application vulnerabilities. Ransomware activity hit a record monthly high in December 2024, highlighting year-end risk concentration for enterprises.

SQL injection occurs when legacy forms use string concatenation in database queries rather than parameterized queries.

 An attacker can modify form parameters to access clinical trial data, proprietary drug formulations, or manufacturing processes. Cross-site scripting allows malicious scripts to be embedded in web forms, compromising user credentials and hijacking authenticated sessions.

Authentication weaknesses compound these vulnerabilities.

 Legacy systems frequently lack multi-factor authentication, implement weak password policies, and use insecure session management. Recent incidents underscore the operational impact. 

, a pharmaceutical R&D company, was hit in 2025 when attackers encrypted parts of its network, shut down systems, and forced operations offline while claiming to have stolen over 170 GB of sensitive data. In Germany, pharmaceutical wholesaler AEP faced similar disruption when IT systems were partially encrypted, putting medicine deliveries to more than 6,000 pharmacies at risk. The 

 in early 2024 exposed data from at least 27 pharmaceutical and biotechnology companies, resulting in a $40 million settlement agreement finalized in 2025.

What are the Risks of Using Third-Party Platforms?

When pharmaceutical companies use third-party web form platforms or cloud services, they create vendor relationships that extend their attack surface.

 Legacy implementations often use consumer-grade tools never designed for life sciences compliance—tools that cannot provide proper security documentation, lack encryption, and store data in unsecured locations.

This creates cascading liability. According to recent data, 

 companies report being negatively affected by breaches in their third-party ecosystem.

 Report revealed that third-party responsibility for breaches doubled from 15% to 30% between 2024 and 2025.

 When breaches originate from third-party systems, the 

Clinical trials present third-party challenges. Contract Research Organizations and technology platforms collect patient recruitment data, informed consent documentation, and clinical endpoints worth hundreds of millions.

 Legacy forms in these environments often cannot enforce data localization requirements or provide the transfer safeguards required under GDPR's 

Beyond security and compliance risks, many organizations spend 60% to 80% of IT budgets just maintaining legacy systems—starving modernization and security uplift.

Organizations hesitate to modernize due to concerns about data migration complexity, system downtime during clinical trials, validation requirements for GxP systems, and high upfront costs.

Yet the cost of inaction escalates. IBM research indicates 58% of breach costs in pharmaceutical companies continue accumulating after the first year.

 This extended financial impact distinguishes pharmaceutical breaches from those in other sectors. The extended exposure period amplifies damages, regulatory scrutiny, and reputational harm with research partners and investors.

Organizations using legacy web forms need to act immediately. Start by inventorying every form that collects sensitive data—clinical trial information, adverse event reports, laboratory results, regulatory submissions—and evaluate whether it meets 21 CFR Part 11, GDPR, and GxP requirements. Implement TLS 1.2 or higher encryption for all data transmission and AES-256 encryption for data at rest. Add multi-factor authentication to all systems handling proprietary research data or clinical information. Verify security agreements are in place for every third-party form platform and assess vendor compliance practices.

Long-term compliance requires replacing legacy forms with validated, GxP-compliant platforms that provide built-in encryption, comprehensive audit trails meeting 21 CFR Part 11 requirements, role-based access control, and complete validation documentation including IQ/OQ/PQ protocols. Modern solutions must also offer data residency controls for GDPR compliance and integration capabilities with CTMS, EDC, and LIMS systems.

 is explicit: systems without audit trails/user login should be replaced in the short to medium term.

 As one expert notes, "no audit trail function will NOT work in a digitalized laboratory."

The pharmaceutical and life sciences sector cannot afford to treat web forms as low-priority infrastructure. Every form represents both a potential entry point for proprietary research data and an attack surface for sophisticated threat actors targeting intellectual property. Organizations that continue relying on legacy systems without modern security controls face mounting financial and operational consequences that will only worsen as regulatory scrutiny intensifies and attackers refine their tactics against known vulnerabilities.

The question is no longer whether to modernize web form infrastructure, but how quickly organizations can implement secure alternatives before the next breach makes the decision for them.

Frank Balonis is chief information security officer and senior VP of operations and support at 

, with more than 20 years of experience in IT support and services. Since joining Kiteworks in 2003, Frank has overseen technical support, customer success, corporate IT, security and compliance, collaborating with product and engineering teams. He holds a Certified Information Systems Security Professional (CISSP) certification and served in the U.S. Navy. He can be reached at fbalonis@kiteworks.com. Check out the 

 for more details on data security and compliance risk.

CybelAngel REACT. Reviewing pharmaceutical threats in 2025. CybelAngel. Published October 9, 2025. 

https://cybelangel.com/blog/pharmaceutical-threats-2025/

Ninjio. A Prescription For Disaster: Human Cybersecurity For The Pharmaceutical Sector. Ninjio. 

https://app-na1.hubspotdocuments.com/documents/5377751/view/1655829371?accessId=c8d6d6

IntuitionLabs. Automating audit trail compliance for 21 CFR Part 11 & Annex 11. IntuitionLabs. Published August 3, 2025. 

https://intuitionlabs.ai/articles/audit-trails-21-cfr-part-11-annex-11-compliance

GMP Compliance. How to handle legacy systems if no audit trail is available or a user login is not possible. GMP Compliance. Published April 7, 2020. 

https://www.gmp-compliance.org/gmp-news/how-to-handle-legacy-systems-if-no-audit-trail-is-available-or-a-user-login-is-not-possible

FormAssembly. The ultimate guide to HIPAA compliant forms and database design. FormAssembly. Published January 26, 2025. Accessed April 8, 2026. 

https://www.formassembly.com/blog/hipaa-compliant-data/

InCountry Staff. Essentials and challenges of healthcare data sovereignty laws. InCountry. Published October 27, 2024. Accessed April 8, 2026. 

https://incountry.com/blog/essentials-and-challenges-of-healthcare-data-sovereignty-laws/

Help Net Security. Attackers are coming for drug formulas and patient data. Help Net Security. Published September 11, 2025. Accessed April 8, 2026. 

https://www.helpnetsecurity.com/2025/09/12/ciso-pharma-cybersecurity-risks/

HIPAA Journal. Cencora & The Lash Group settle data breach litigation for $40 million. The HIPAA Journal. Published September 23, 2025. Accessed April 8, 2026. 

https://www.hipaajournal.com/cencora-cyberattack-data-breach/

Pharmaphorum. Defending against third-party security risks for pharma companies. Pharmaphorum. Accessed April 8, 2026. 

https://pharmaphorum.com/digital/defending-against-third-party-security-risks-pharma-companies

Fortify Data. Top third-party data breaches in 2025. Fortify Data. Published 2025. Accessed April 8, 2026. 

https://fortifydata.com/blog/top-third-party-data-breaches-in-2025/

Xia L, Cao Z, Zhao Y. Paradigm Transformation of Global Health Data Regulation: Challenges in Governance and Human Rights Protection of Cross-Border Data Flows. Risk Manag Healthc Policy. 2024;17:3291-3304. doi:10.2147/RMHP.S450082

Modernizing technology is urgent as legacy web forms expose pharma companies to breaches averaging $5.1 Million

Hidden Liability: Why Legacy Web Forms Put Life Sciences Organizations at Critical Risk

BMS and Oxford BioTherapeutics Partnership on T-Cells

On April 9, 2026, Oxford BioTherapeutics announced a multi-year collaboration with Bristol Myers Squibb focused on the discovery and development of T-cell engager therapies for solid tumors.

 According to the agreement, Oxford BioTherapeutics will use its OGAP-Verify platform to find specific targets in solid cancers and create new T-cell engager molecules. Bristol Myers Squibb will then lead subsequent research, development, and commercialization activities.

The deal places target identification and the generation of development candidates within Oxford BioTherapeutics before handoff to Bristol Myers Squibb for the later-stage work.

 That division of labor reflects a new industry trend that is shifting toward more modular collaboration models, in which specialized platform technologies are brought in at the discovery and preclinical stages rather than developed in-house.

What Does the OGAP-Verify Platform Contribute?

The OGAP-Verify platform is designed for highly sensitive identification of oncology targets with attributes that support downstream drug development, with a particular emphasis on tumor selectivity.

 Oxford BioTherapeutics' remit extends beyond target identification to include the design and delivery of development candidates, a scope that signals the platform's positioning as less of a discovery tool than a preclinical development tool.

"This new partnership builds on the proven strength of our platform to identify and validate highly differentiated, tumor-selective targets and reflects the growing confidence in our ability to translate that science into development-ready therapeutic candidates," said Christian Rohlff, chief executive officer, Oxford BioTherapeutics, in a press release.

T-cell engagers for solid tumors remain a challenging area of oncology drug development.

Unlike hematological malignancies, solid tumors present significant obstacles around target accessibility, tumor microenvironment immunosuppression, and on-target off-tumor toxicity. The emphasis on tumor-selective targets in this collaboration speaks directly to those challenges.

Why Does the Timing of This Deal Matter for the Broader Field?

This agreement is the third major pharmaceutical collaboration Oxford BioTherapeutics has entered in the past twelve months, following partnerships with GSK and Roche in 2025.

The pace these deals are being drafted suggests that large pharmaceutical companies are actively seeking external platform capabilities for oncology target discovery rather than relying solely on internal research infrastructure.

"Collaborating with Bristol Myers Squibb, a global leader in oncology, represents an important milestone for OBT and underscores the momentum behind our partnerships with leading pharmaceutical companies," said Rohlff, in the press release.

 "By combining OGAP-Verify's discovery and validation capabilities with Bristol Myers Squibb's expertise in translating oncology innovation into clinical and commercial outcomes, we are confident that together we can advance a new generation of innovative cancer therapies that have the potential to make a meaningful difference for patients."

Deals at this stage are often early signals of what assets may eventually require scale-up and manufacturing support.

 Biologics-based T-cell engagers, including bispecific formats, carry well-documented complexity in terms of expression systems, purification, and formulation. Monitoring which targets and molecular formats emerge from collaborations like this one can inform capacity planning and technology readiness well ahead of late-stage development timelines.

How Else Is BMS Approaching the Cancer Care Pathway?

The T-cell engager collaboration with Oxford BioTherapeutics sits at the discovery end of oncology drug development, but Bristol Myers Squibb is also investing in infrastructure that shapes the detection of cancer.

 aims to accelerate early detection of lung cancer by deploying AI radiology algorithms through Microsoft's imaging network. The system is designed to help detect surface lung nodules that might otherwise go unnoticed, and to track patients with incidental findings through follow-up care pathways. This is an area where current loss-to-follow-up rates exceed 50%. The signal is clear, that Bristol Myers Squibb is investing in its oncology pipeline at multiple levels, they are looking to cover novel target identification through to the point of diagnosis.

Oxford BioTherapeutics. Oxford BioTherapeutics Enters Strategic Collaboration with Bristol Myers Squibb to Discover and Develop Next-Generation T-cell Engagers for Solid Tumours. Oxford BioTherapeutics; April 9, 2026. 

https://oxford-biotherapeutics.lon1.cdn.digitaloceanspaces.com/OBT-BMS-2026-04-09.pdf

Bristol Myers Squibb. Bristol Myers Squibb announces collaboration with Microsoft to advance AI-driven early detection of lung cancer. Bristol Myers Squibb. Published January 19, 2026. 

https://news.bms.com/news/corporate-financial/2026/Bristol-Myers-Squibb-Announces-Collaboration-with-Microsoft-to-Advance-AI-Driven-Early-Detection-of-Lung-Cancer/default.aspx

Oxford BioTherapeutics and Bristol Myers Squibb formed a multi-year alliance to discover and advance solid-tumor T‑cell engagers. Oxford will apply OGAP‑Verify to identify tumor-selective antigens and generate development-ready candidates, with BMS leading later research, clinical development, and commercialization. The structure reflects modular partnering to access specialized discovery platforms amid persistent solid-tumor hurdles, including target accessibility, immunosuppression, and on-target off-tumor risk. The deal also flags future biologics manufacturing complexity and complements BMS investments in AI-enabled lung-cancer detection and follow-up pathways overall.

BMS and Oxford BioTherapeutics partner to develop tumour-selective T-cell engagers, signalling pharma's growing reliance on specialist discovery platforms.

How Pharma Is Outsourcing Oncology Target Discovery in 2026

Susan Schniepp, Regulatory Compliance Associates Inc.

Susan Schniepp, Regulatory Compliance Associates Inc., shared her insights on the transformative role of emerging technologies in drug manufacturing. Having participated in the planning committees for P

, Schniepp is at the forefront of introducing new technologies like digital twins and artificial intelligence to the industry.

Check out the 3-part video interview with Schneipp:

Digital Twins and the Future of Pharma Validation

Identifying Data Integrity Hotspots Using AI Technology

PharmTech: How Do You Define a Digital Twin in the Context of Pharmaceutical Manufacturing?

Schniepp: My understanding of a digital twin is that it is a system designed to mimic exactly what you have put into live operation. It runs alongside your actual production line. Potential issues come when the two systems, the physical and the digital, begin to divert from one another. If they are no longer in sync, it triggers a specific response from the team, such as a new validation, a technical correction, or another corrective activity to bring them back into alignment.

How Does This Tech Help Address Concerns of Data Integrity?

Data integrity is a major concern as we move away from traditional paper systems or middle electronic systems. In those older models, humans handled every document and performed every approval manually. Now, we use digital twins to identify hotspots, specific areas where there is a high potential for data integrity violations based on how documents are being handled. Once the AI identifies these risks, the human staff can shore up"the system to prevent a violation from ever actually occurring.

How Does AI Change Workflow Compared to a Middle Electronic System?

A middle electronic system is like Documentum, where you use electronics to move files around, but a human still has to physically look at and approve everything. With AI and machine learning, we are allowing the machine to do much more. The system itself collects the data and assures its correctness. The human's role shifts from doing the primary approval of every detail to reviewing the data the digital twin or system has already aggregated.

How Does AI Impact the Batch Release Process?

This is a significant shift for the industry. AI acts like one centralized brain that compiles information from various sources that a person would normally have to hunt for manually. The AI creates a dossier for the batch, noting that parameters were met and identifying any deviations. It can then essentially tell the human, "All of these things related, and there were no deviations. You can release this batch.” This speeds up the process significantly because the human professional is reviewing a summarized dossier rather than starting the data collection from scratch.

What Happens When the Human Professional Disagrees with the Machine's Assessment?

We treat a conflict between the human's opinion and the machine's data as a deviation. Because our industry relies on Corrective and Preventive Action systems, this discrepancy prompts a formal investigation to determine why these two events are conflicting. The traditional model is to investigate the root cause. Since the technology is still so new, I believe the human should take precedence. The investigation should focus on why the digital twin conflicts with the human, though we may occasionally find that the human was actually the one who was wrong.

Do You Have Concerns About The Human-In-The-Loop Model?

The industry is currently struggling with exactly where to place the human in the loop to be most efficient. My concern is that at some point, the machine will absorb so much data and learn so much faster than a person can that it will become more capable than the human. I worry that the human will be out of the loop eventually. However, for now, the human must remain the final decision-maker, absorbing the data provided by the AI to make the final call on whether a batch is safe for release.

Emerging manufacturing technologies are reshaping validation, data integrity assurance, and batch release decision-making. Digital twins are positioned as parallel, continuously updated models of live operations that flag divergence requiring corrective action, revalidation, or technical remediation. AI/ML shifts quality workflows from manual document review toward automated data aggregation, verification, and risk-based identification of data integrity hotspots. For batch disposition, AI can compile cross-system evidence into a release-ready dossier, accelerating timelines. Disagreement between human judgment and machine output is treated as a deviation triggering CAPA-driven investigation, with human precedence maintained.

Susan Schniepp discusses how AI and digital twins speed up pharma batch release and detect data integrity issues while maintaining human oversight.

Managing Deviations Between Humans and Digital Twin Data

FDA Approves First Tablets For Type 2 Diabetes

On April 7, 2026, the FDA granted approval to multiple generic-drug applicants for Farxiga (dapagliflozin) tablets, the first generics featuring the compound to reach the US market.

 The approvals cover two indications, the primary being reducing the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus who have either established cardiovascular disease or multiple cardiovascular risk factors. It is also an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Type 2 diabetes is a chronic condition that develops over many years, occurring when the body does not use insulin well and cannot keep blood sugar at normal levels.

 More than 40 million Americans have diabetes with 90% to 95% of that population having type 2 diabetes.

Farxiga works as a sodium-glucose cotransporter 2 inhibitor, which reduces the reabsorption of glucose and sodium in the kidneys.

 The tablets are available in 5 mg and 10 mg strengths, with bioequivalence to the reference listed drug required as a condition of approval.

What Safety and Labeling Requirements Apply to These Generic-Drug Applicants?

Farxiga is contraindicated in patients with a history of a serious hypersensitivity reaction to dapagliflozin or any of the excipients.

 Warnings include diabetic ketoacidosis in patients with type 1 diabetes mellitus and other ketoacidosis, and volume depletion. The most common side effects reported in clinical trials were female genital mycotic infections, nasopharyngitis, and urinary tract infections. Healthcare providers should review the full prescribing information for complete safety and dosing information, and manufacturers should ensure their labeling reflects the full scope of these requirements before commercialization.

The full list of approved applicants is available through the Approved Drug Products with Therapeutic Equivalence Evaluations.

 Given that approvals were granted to multiple manufacturers simultaneously, companies should anticipate a competitive launch environment and plan production schedules and market entry strategies accordingly.

How Are Recent Type 2 Diabetes Approvals Reshaping Injectable Treatment Development?

While the generic dapagliflozin approvals mark a significant moment for oral glucose-lowering therapy, the injectable insulin space is undergoing a parallel shift.

 On March 26, 2026, the FDA approved Awiqli (insulin icodec-abae) injection 700 units/mL, the only once-weekly, long-acting basal insulin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

The approval is supported by the Onwards phase IIIa clinical program, which comprised four randomized, active-controlled, treat-to-target trials in approximately 2680 adults with uncontrolled type 2 diabetes.

 The program evaluated once-weekly Awiqli against daily basal insulin and demonstrated efficacy in the primary endpoint of A1C reduction across the trial program. The safety profile was consistent with the daily basal insulin class, with common adverse events including hypoglycemia, injection site reactions, and weight gain.

Awiqli is administered at a concentration of 700 units/mL using a dedicated pen injector, a delivery system designed to minimize the risk of dosing errors.

 The prescribing information includes specific guidance around pen use, dose selection, and the risk of mix-ups with other injectable products.

"Research supports weekly injectable diabetes medications can be associated with improved patient adherence," Julio Rosenstock, MD, a principal investigator for the ONWARDS trial program, stated in a press release.

 "Having a weekly basal insulin option like insulin icodec-abae may reshape insulin management in adults with type 2 diabetes, giving them a routine that feels more manageable as they work toward their blood sugar goals."

U.S. Food and Drug Administration. FDA approves first generic dapagliflozin tablets. Published April 6, 2026. Accessed April 8, 2026. 

http://www.fda.gov/drugs/drug-alerts-and-statements/fda-approves-first-generic-dapagliflozin-tablets

Novo Nordisk A/S. Awiqli approved in the US, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes. Published March 27, 2026. Accessed April 8, 2026. 

https://www.prnewswire.com/news-releases/fda-approves-novo-nordisks-awiqli-the-first-and-only-once-weekly-basal-insulin-treatment-for-adults-with-type-2-diabetes-302726839.html

FDA approvals introduced the first US generics of dapagliflozin tablets (5 mg, 10 mg) for type 2 diabetes, covering heart failure hospitalization-risk reduction in high cardiovascular-risk adults and adjunctive glycemic control. Bioequivalence to the reference listed drug is required, alongside full alignment with contraindications, warnings, and adverse-reaction labeling. Concurrently, insulin development advanced with approval of once-weekly insulin icodec-abae (Awiqli) 700 units/mL, supported by the ONWARDS phase IIIa program showing A1C lowering comparable to daily basal insulins.

The FDA approved the first generic dapagliflozin tablets, opening a competitive US market for pharma manufacturers and generic-drug developers.