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Brand manufacturer Acorda is fending off at least six different generic challenges filed in the last few weeks to its multiple sclerosis drug Ampyra. Read More
In a blow to AbbVie’s efforts to head off generic competition on its AndroGel 1%, the FDA said Irish drugmaker Perrigo’s testosterone gel product is bioequivalent and interchangeable. Read More
A federal court has granted Mylan’s request for a temporary restraining order to halt all sales of competitor Apotex’s generic version of Paxil CR, the latest step in Mylan’s claim to generic exclusivity on GlaxoSmithKline’s blockbuster antidepressant. Read More
After asking drugmakers in 2011 to voluntarily withdraw pain medications containing more than 325 milligrams of acetaminophen over safety issues, the FDA has pulled the remaining ANDAs from firms that either failed to submit sufficient data with their withdrawal applications or didn’t submit an application at all. Read More
A group of third-party pharmaceutical payers is moving to settle part of a class action lawsuit against Pfizer-subsidiary King Pharmaceuticals and generics maker Mutual Pharmaceutical over their alleged collusion to delay a generic of the muscle relaxant Skelaxin. 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
Canadian pharmaceutical company Duchesnay has filed a lawsuit against generic manufacturer Actavis over its challenge to Duchesnay’s morning sickness drug Diclegis. Read More
Brand manufacturers who use risk evaluation and mitigation strategies (REMS) to delay generic competition by denying product samples to would-be ANDA filers are costing pharmaceutical payers billions of dollars each year, according to a new study commissioned by GPhA. Read More
Iowa’s Supreme Court has once again confirmed that brand manufacturers can’t be held liable for injuries sustained when patients take a generic version of their drug. But the ruling also left generics makers slightly more liable to product injuries than in most recent “failure-to-warn” cases. Read More
The FDA has been asked to turn over a trove of information related to the development of its proposed generic drug labeling rule, with GOP leaders of a key House investigative committee claiming the agency engaged in “dubious” behaviors in the rulemaking process. Read More
Sandoz has become the first drugmaker to announce FDA acceptance of a biosimilar application with its cancer treatment filgrastim, a milestone that indicates the highly anticipated class of products may soon come to market more than four years after Congress approved a regulatory pathway. Read More