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The FDA is giving industry until March 9 to again weigh in on the controversy surrounding generic first-filer exclusivity determinations and other GDUFA-related issues first raised at a September public hearing. Read More
The FDA gave tentative approval to Mylan’s ANDA for a generic Nexium earlier this month, but denied final approval due to lasting exclusivity protections — almost guaranteeing Teva the only generic version of the blockbuster heartburn drug on the market for months to come.
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Mylan and Sandoz need only FDA approval to launch their generic versions of Teva’s blockbuster MS drug Copaxone, after a federal judge refused Teva’s request to block generic entry. Read More
Long-awaited guidance on designating a biosimilar as interchangeable with the reference product may soon be in the offing, based on an FDA request for comments on a proposed collection of information. Read More
Generic drugmakers charge a December draft guidance doesn’t go far enough in enabling them to obtain bioequivalence testing batches for drugs protected by REMS product safety protocols. Read More
The FDA slapped Canadian generics maker Apotex with a warning letter for serious lapses in current good manufacturing practices at its Bangalore, India, finished product plant. Read More
The FDA has again found Upsher-Smith Laboratories’ testosterone gel Vogelxo therapeutically equivalent to Auxilium’s Testim — knocking down Auxilium’s citizen petition demanding higher hurdles for 505(b)(2) NDAs aimed at its therapy. Read More
The FDA last week granted final approval to Mylan and Watson for generic versions of Pfizer’s blockbuster arthritis drug Celebrex, allowing the companies to share 180-day exclusivity with Teva. Read More
After serving as FDA commissioner for six years, Margaret Hamburg has resigned, ending a tenure during which the agency boosted its focus on drugs for unmet needs, strengthened policing of compounding pharmacies and increased drug approvals. Read More
Drugmakers claiming a product is protected by a patent will need to make much more detailed justifications of their claims under a rule proposed by the FDA on Feb. 5. Read More
Hospira is looking to add another biosimilar candidate to its growing pipeline by partnering with Pfenex to develop and market a biosimilar of Genentech’s retinal disease therapy Lucentis. Read More