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Inspections at beleaguered Indian generics firm Wockhardt’s Illinois plant found quality control issues ranging from poor cleanliness to shoddy product testing and incomplete record-keeping, the FDA said. Read More
Teva cleared a major hurdle this month in its bid to launch a generic version of Bristol-Myers Squibb’s hepatitis B drug Baraclude after a federal appellate court upheld a lower court’s decision invalidating the drug’s patent. Read More
European regulators said they will reinstate a good manufacturing practice certification for Ranbaxy’s manufacturing facility in Toansa, India, following an inspection that found the generic drugmaker had addressed reported GMP violations. Read More
A federal judge tossed out claims over a patent in Sandoz’s bid to launch a generic version of United Therapeutics Corporation’s pulmonary arterial hypertension drug Remodulin, but two more patent challenges remain. Read More
Generic firm Glenmark Pharmaceuticals wants a federal appeals court to rehear its case over rights to the combination hypertension drug Tarka, arguing that an April decision was invalid because it incorrectly attributed exclusive patent rights. Read More
Endo Pharmaceuticals and Impax Laboratories are facing a lawsuit alleging that the two drugmakers conspired to keep a generic version of Endo’s pain medication Opana ER off the market. Read More
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