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Mumbai-based Cipla agreed to acquire US companies InvaGen and Exelan, giving Cipla US tablet and capsule production capacity, a more diversified portfolio, and market access.

Cipla Acquires US Companies InvaGen and Exelan

Geoffrey Wu, PhD*, is a regulatory review officer, geoffrey.wu@fda.hhs.gov.

Lane Christensen, PhD, is a chemist at FDA, CDER’s Office of Generic Drugs.

Thomas O’Connor is chemical engineer, science staff at the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA.

Frank Holcombe Jr., PhD is with the Center for Drug Evaluation and Research, FDA

Susan Rosencrance, PhD is with the Center for Drug Evaluation and Research, FDA

Andre Raw, PhD is with the Center for Drug Evaluation and Research, FDA

Kristina Adams, PhD is with the Center for Drug Evaluation and Research, FDA

Xiaochuan Yang, PhD is with the Center for Drug Evaluation and Research, FDA

Min Li, PhD is with the Center for Drug Evaluation and Research, FDA

An analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.

Regulatory Considerations for Controlled Correspondence Related to Generic Drug Chemistry

Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.

Biosimilars and Follow-on-Biologics Market to Hit $35 Billion Globally by 2020

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

In a new draft guidance, FDA proposes the use of a nonproprietary name plus a four-letter suffix to identify all biologic products, both new and old.

FDA Releases Guidance on Biosimilar Nomenclature, Requests Comments on Interchangeable Product Naming

US generics manufacturer Amneal acquires a former J&J plant in Ireland.

Amneal Purchases Manufacturing Site in Ireland

Teva has launched the generic version of almotriptan malate (Axert), 6.25 mg and 12.5 mg, in the United States.

Teva Launches First Generic Axert Tablets in the US

The agency takes action against websites that illegally sell unapproved medications.

FDA Fights Online Counterfeit Drugs

BPTF seeks changes in performance goals and fee payment schedule in GDUFA renegotiations.

BPTF Calls for Changes to GDUFA

The product, marketed as Sirdupla in the United Kingdom, is the generic version of GSK’s beta agonist and corticosteroid combination treatment for asthma.

Mylan Launches First Generic Combination Therapy for Asthma

In a Citizen Petition to FDA, AbbVie calls the current biosimilar labeling practices “legally unsound.”