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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Generic drugmakers charge a December draft guidance doesn’t go far enough in enabling them to obtain bioequivalence testing batches for drugs protected by REMS product safety protocols.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
A proposal to lift restrictions on how drugmakers can promote products on social media and another that would grant up to 15 years of generics-free exclusivity to drugs approved to treat an unmet medical need are emerging as controversial issues in a proposal to overhaul the FDA’s drug approval processes. 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
Colorado lawmakers have introduced a biosimilar substitution bill that closely mirrors at least one aspect of compromise language unveiled by industry leaders in December — elimination of prescriber notification in favor of entering a switch into an electronic database. Read More
Actavis will become the UK’s largest generics supplier once its roughly $461 million acquisition of Auden Mckenzie closes in the first quarter of this year. Read More