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The FDA is withdrawing approval of one NDA and four ANDAs for ondansetron, effective immediately, due to a potentially life-threatening complication with the drug. Read More
Shire’s blockbuster attention deficit hyperactivity disorder drug Intuniv is facing competition as four generic versions of the therapy hit the U.S. market. Read More
Buyers of heartburn drug Nexium are seeking an injunction against Ranbaxy and AstraZeneca in pay-for-delay litigation, arguing that their motion is supported by a recent Second Circuit ruling upholding an injunction requiring Actavis to keep an older version of Alzheimer’s drug Namenda on the market. Read More
Drugmakers and patients can now access risk evaluation and mitigation strategies for FDA-approved drugs, thanks to an updated website launched by the FDA on June 17. Read More
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