Generic Drugs

Sep 07, 2018
More than 120 healthcare organizations plan to bring competition to generic drug market.
Sep 06, 2018
By Pharmaceutical Technology Editors
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.
Sep 04, 2018
By Pharmaceutical Technology Editors
As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.
Sep 02, 2018
Pharmaceutical Technology
The European Commission’s proposed amendment on SPC waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars.
Aug 17, 2018
By Pharmaceutical Technology Editors
FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector.
Jul 19, 2018
In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.
Jun 22, 2018
By Pharmaceutical Technology Editors
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.
Jun 22, 2018
By Pharmaceutical Technology Editors
The approval is intended to increase patient access to treatment for opioid addiction.
Jun 22, 2018
By Pharmaceutical Technology Editors
The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.
Jun 13, 2018
Pharmaceutical Technology's In the Lab eNewsletter
By Pharmaceutical Technology Editors
Cambrex expands its generic API research and development capabilities at its Milan, Italy site.
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