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A federal judge rejected AstraZeneca’s motion to block generics from making versions of its inhaled corticosteroid Pulmicort Respules, and instead will consider that request and broader patent issues on the drug when the trial resumes this fall. Read More
Manufacturer Hospira’s 2005 withdrawal of its leucovorin injection was not done for effectiveness or safety reasons, the FDA said, paving the way for new ANDAs on the generic anemia drug. Read More
The FDA for the first time has consolidated all elements that generic manufacturers must include in their ANDAs in an effort to increase the success rate of new submissions. Read More
Delaware has become the latest state to let pharmacists substitute biosimilar products for the prescribed biological reference product, a move cheered by a national biopharmaceutical trade group. Read More
The generic drug industry wants the FDA to ensure new requirements for packaging and technologies aimed at curbing opioid abuse don’t result in barriers to market entry for generic makers. Read More
A federal appeals court needs to rethink its definition of “a patient” or risk upholding a dangerous precedent in future Hatch-Waxman cases, trade groups BIO and PhRMA argued after a recent patent ruling on the colon cleanser Suprep. Read More
The FDA and Customs and Border Protection (CBP) yesterday began accepting applications for an 18-month pilot of a “trusted trader” program to reduce inspections and oversight of imports from drugmakers that establish tough internal import control programs of their own. Read More
Drugmakers operating in the EU must submit additional information to the European Medicines Agency on their authorized products starting immediately, and update previously submitted information by year’s end. Read More
Drugmakers hoping to market generic and biosimilar products quickly in Brazil should pair up with the branded firms to facilitate the application process, according to an updated rule that aims to speed generic approvals. Read More
Drugmakers submitting regulatory filings in the U.S., Europe and Japan generally may use pharmacopeia texts on dosage units interchangeably in the three regions, according to a final FDA guidance that adopts guidelines from the International Conference on Harmonization. Read More