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The FDA wants generics makers to design tablets and capsules to be similar in size and shape to their reference listed drug to ensure patient acceptance and compliance, according to final guidance issued June 18. Read More
Sandoz wasted no time in launching its generic version of Copaxone in the U.S. after the U.S. Court of Appeals for the Federal Circuit again invalidated Teva’s patent on the blockbuster multiple sclerosis drug. Read More
Generics industry groups told FDA officials during a June 15 public meeting that review times and approvals of generic drugs have slipped significantly since implementation of the Generic Drug User Fee Act, and they called for major changes when the program is reauthorized in fiscal 2018. Read More
The judge says the FDA did not unlawfully decide to delay final approval of Veloxis Pharmaceuticals’ extended-release immunosuppression drug. Read More
The U.S. Court of Appeals for the Federal Circuit has affirmed a lower court ruling that Celgene did not infringe on a Teva subsidiary’s patent when it marketed its cancer drug Abraxane. Read More
The International Conference on Harmonisation has released a Q&A guide aimed at clarifying requirements for quality management, documentation, equipment cleaning and more in its Q7 guideline on GMPs for active pharmaceutical ingredients. Read More
The National Institutes of Health is working quickly to correct major lapses in its drug compounding unit so officials will be able to ask the FDA to register it as a cGMP manufacturing facility subject to periodic regulatory inspections. Read More
Valeant Pharmaceuticals is recalling more than 93,000 bottles of nifedipine extended-release 90 mg tablets throughout the U.S. because they dissolve too quickly. Read More