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The FDA has shed light on how amendments to an NDA, BLA or supplement may affect review timelines established under the 2012 prescription drug user fee program. Read More
New Jersey-based Eisai is suing the FDA over the exclusivity clock assigned to two of its products, claiming the government arbitrarily shortened its five-year exclusivity period from generics competition. Read More
Subsidiaries of generics maker Hetero Drugs can move forward with generic versions of the kidney drug PhosLo despite an ongoing lawsuit brought by patent owner Roxane Laboratories. Read More
To improve ANDA submissions, the FDA should spend more time with generics companies before they file an application, as is done with brand manufacturers in the run-up to an NDA, the Generic Pharmaceutical Association says. Read More
Eli Lilly and Boehringer Ingelheim have won tentative FDA approval for their insulin product Basaglar, which is considered the biosimilar of a Sanofi product in Europe but is being reviewed as its own NDA in the United States. Read More
Endo Pharmaceuticals and Impax Laboratories are facing a second proposed class action lawsuit over an alleged pay-to-delay deal that put off a generic launch of Endo’s pain medication Opana ER. Read More
Sun Pharmaceutical recalled more than 450,000 drug units because the active ingredient wasn’t manufactured in compliance with FDA good manufacturing practices, creating another quality headache for the Indian drugmaker. Read More
The FDA is mulling changes to the way it determines eligibility for 180-day generic exclusivity, including opening up the exclusivity decision-making process to the public, and it’s inviting industry to offer feedback on the idea. Read More
A patient advocacy group is using a recently created review pathway through the U.S. Patent and Trademark Office to challenge the patent on Wyeth’s antibiotic Tygacil outside a Hatch-Waxman ANDA. Read More
Mylan and Sandoz have filed a legal brief with the U.S. Supreme Court challenging Teva’s appeal to salvage the patent protection on its blockbuster multiple sclerosis drug Copaxone. Read More
Generic versions of Depomed’s shingles drug Gralise are unlikely in the near future after a federal judge sided with the brand manufacturer’s patent infringement suit against a 2012 ANDA filed by Actavis. Read More