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Indian generics maker Lupin Pharmaceuticals is being sued by Valeant Pharmaceuticals subsidiary Bausch + Lomb and Senju Pharmaceuticals over its ANDA for Prolensa eye drops. Read More
The FDA is seeking a permanent injunction against a California drugmaker, saying the company manufactures and distributes over-the-counter vaginal products without proper regulatory approval. Read More
The FDA would require biosimilars to carry the same name as their reference drug counterparts under a proposal being pushed by healthcare payers and GPhA. Read More
The FDA warned another compounding pharmacy for mixing unapproved drugs and for poor quality, with Pharmacy Creations becoming the latest compounder to challenge agency enforcement of its activities. Read More
The FDA has granted breakthrough therapy designation to Amgen’s bispecific T cell engager (BiTE) antibody blinatumomab for the treatment of a rapidly progressing blood and bone marrow cancer, paving the way for speedy development and review of the drug. Read More
The FDA Tuesday released two major guidances for compounding pharmacies. One establishes for the first time an interim GMP framework for large compounders that register with the agency as outsourced facilities. The second finalizes draft enforcement guidance spelling out what enforcement smaller, traditional compounders can expect from the agency. Read More
The FDA is renewing the call for nominations for the list the agency is building of active drug substances that can be used to compound drug products, saying many of the responses to its December effort to build the list were inadequate. Read More
Manufacturers of generic versions of cholesterol drugs Darvocet and Darvon can’t be held liable for not changing their labels to note safety warnings without prior FDA approval, an appeals court has ruled, further entrenching generic drugmakers’ protections from failure-to-warn and other lawsuits. Read More
Over the next five years the FDA plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More