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A U.S. senator is urging the FDA to act on a potential shortage of the antibiotic doxycycline while he mulls legislation that would allow the agency to step in sooner to deal with shortages. Read More
Baxter continues to be plagued with particulate problems, recalling two lots of a dialysis solution and a lot of saline solution that is currently in short supply. 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
AstraZeneca is suing India-based generics firm Zydus Cadila to block its bid for a version of the brand manufacturer’s acid-reflux drug Nexium. Read More
New Jersey-based Mutual Pharmaceutical and two other generics firms are suing brand manufacturer Reckitt Benckisser for breach of contract, alleging that RB reneged on a license agreement to provide generic supplies of its cold and flu medicine Mucinex for sale. Read More
Boehringer Ingelheim is suing Amneal Pharmaceuticals over its bid to make a generic version of the brand manufacturer’s anti-stroke drug Aggrenox. Read More
A group of brand and generic drugmakers has asked a federal judge to toss out a multidistrict class action lawsuit accusing them of colluding to delay generic versions of the painkiller Lidoderm, arguing that a patent infringement settlement between the parties was anything but anticompetitive. Read More
Indian generics firm Dr. Reddy’s has filed the first patent challenge against Teva’s blockbuster multiple sclerosis drug Copaxone’s 40 mg, introducing a new chapter to the Israeli drugmaker’s efforts to protect its multibillion dollar product. Read More
Complaints of particulates found in vials of nine lots of Cubist Pharmaceuticals’ anti-infective drug Cubicin prompted the company to initiate its second recall of the drug in as many days. Read More
A patient advocacy group is using a recently created pathway for challenging generic drugs through the U.S. Patent and Trademark Office to contest the patent on Wyeth’s antibiotic Tygacil outside a Hatch-Waxman ANDA. Read More
Drugmakers are worried that FDA draft guidance on how to identify and report counterfeit or suspicious goods could lead to numerous false alarms and potential shortages unless the guidance is amended. Read More