Zydus Pharmaceuticals notified Somaxon Pharmaceuticals of its FDA application to market a generic version of sleeping drug Silenor. Somaxon said it is reviewing the notice and "intends to vigorously enforce its intellectual property rights relating to Silenor."
Mylan rolled out bromfenac and cyclobenzaprine hydrochloride in the domestic market. They are generic versions of ISTA Pharmaceuticals' eye solution Xibrom and Cephalon's muscle relaxant Amrix, respectively.
Qualitest Pharmaceuticals voluntarily recalled three lots of anti-seizure drug phenobarbital and a painkiller that combines hydrocodone and acetaminophen.
The recall comes after Qualitest discovered that a bottle of the latter medicine carries the former's label. Qualitest said no adverse reactions have been reported.
The FDA began a proceeding aimed at requiring makers of over-the-counter painkillers to add more cautionary warnings to their labels. The labeling suggestions would vary according to the type of painkiller, including the potential for stomach bleeding with aspirin, ibuprofen and other NSAIDs and the potential for liver damage associated with acetaminophen.