Dosage Forms

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

More than 120 healthcare organizations plan to bring competition to generic drug market.

Hospitals Back Generic Drug Production Venture

Novartis will sell selected portions of its Sandoz United States portfolio to Aurobindo Pharma USA for $900 million in cash, plus $100 million in potential earn-outs.

Novartis to Sell Parts of Sandoz in $1-Billion Deal

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

FDA Expands NDMA Investigation to All ARB Class Drugs

Sean Milmo is a freelance writer based in Essex, UK.

The European Commission’s proposed amendment on SPC waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars. 

Disputes Over SPC Waivers

FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector.

First Generic Version of EpiPen Gets Approval

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

FDA Reveals Biosimilar Plan; Gottlieb Blasts Delays

The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.

FDA Publishes User Fee Guidance

The approval is intended to increase patient access to treatment for opioid addiction.

FDA Approves Generic Suboxone Sublingual Film for Opioid Dependence Treatment

FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.

US and EU Talk Inspections, Generics, and Advanced Therapies at Bilateral Meeting

Cambrex expands its generic API research and development capabilities at its Milan, Italy site.

Generic Drugs