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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
Hospira has won a temporary restraining order blocking Mylan from marketing a generic version of its sedative Precedex, which the FDA authorized last week under the controversial section viii statement pathway that foregoes a patent challenge and instead allows manufacturers to “carve out” indications not protected by patents. Read More
Indian generics maker Dr. Reddy’s Laboratories is under investigation for allegedly selling prescription drugs without sufficient child-resistant packaging, the company revealed. Read More
The FDA’s newly created four-point sliding scale of comparability between original biologic products and their biosimilars does not belong in guidance on data to demonstrate that similarity, PhRMA says. Read More
Indian generics makers have hired a U.S.-based lobbyist to head off the threat of a trade downgrade and polish an image that has been tarnished by FDA import bans and warning letters for manufacturing practice violations. Read More
Alabama’s Supreme Court Aug. 15 reaffirmed its ruling that a brand drugmaker can be held liable for damages caused by a generic version of its product if the generic carries warning labels that are drafted by the brand company. Read More
1.7 million treatments will be sent to Burkina Faso, the Democratic Republic of Congo, Burundi, Nigeria, Liberia and Niger in the coming months. Read More