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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
Australia’s Therapeutic Goods Administration is now following Europe’s lead on drug safety oversight in both general and pediatric populations. Read More
A federal appellate judge has ordered brand firm Endo and generics manufacturer Mylan to continue negotiating a court-mandated settlement that will allow Mylan to market a generic version of Endo’s migraine drug Frova. Read More