We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Mylan has further cemented its win in a breach-of-contract lawsuit against GlaxoSmithKline with a court order prohibiting GSK from providing an authorized generic version of the antidepressant Paxil to Mylan’s competitor Apotex. Read More
The FDA admonished Concordia Pharmaceuticals for a telephone sales pitch about its attention deficit hyperactivity disorder drug Kapvay that omits critical risk and dosing information. Read More
Brand manufacturer Mayne Pharma and Warner Chilcott, U.S. marketer of Mayne’s acne drug Doryx, have moved to settle class action claims with third party purchasers that allege the two companies inappropriately delayed generic competition on the product. Read More
Baxter is voluntarily recalling four lots of intravenous solutions in response to customer complaints of plastic and fiber particles in the product, its fourth recall this year related to particulates. Read More
The FDA intends to step up its scrutiny of a company’s data integrity protections during manufacturing inspections, following a series of investigations that caught drugmakers backdating manufacturing records and falsifying data. Read More
Drugmakers are facing tougher hurdles in getting new cancer drugs covered in the UK, according to a U.S industry trade group. But some observers and UK government officials counter that the majority of these expensive treatments are still being widely reimbursed, even if they come with some restrictions. Read More
Massachusetts-based Cubist Pharmaceuticals is suing Fresenius Kabi over its proposed generic version of Cubist’s profitable antibiotic Cubicin. Read More
The FTC gave generics makers a boost last month in their fight to stop brand drugmakers from using REMS restrictions to block access to sample drugs the generics industry needs to prepare ANDAs. Read More
A federal judge has dismissed conspiracy claims against four generic drugmakers and a brand firm in a class-action lawsuit that alleges the companies colluded to keep generic versions of Cephalon’s wakefulness drug Provigil off the market. Read More
A federal judge has tossed out Novartis’ lawsuit against generic firm Alvogen’s challenge to its dementia treatment Exelon Patch, claiming the brand firm failed to show the generic product contained a patented antioxidant. Read More
Avanir Pharmaceuticals has settled with generic firm Ranbaxy over its bid to produce a version of the brand manufacturer’s Nuedexta, the first drug approved in the U.S. to treat pseudobulbar affect (PBA). Read More