Mylan expects to be the first to market with a generic version of a drug for treating patients with gout, the company said Friday, though its filing has triggered a lawsuit from the makers of the branded version.
Actavis is seeking Food and Drug Administration approval for a generic drug used to treat acne, triggering a lawsuit in a federal court from the maker of the branded version, the company said Thursday.
For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.
A bill designed to strengthen the security of the drug supply chain by creating an electronic track-and-trace system and national standards for sterile pharmacy compounding has attracted support from trade groups representing independent pharmacies and generic drug makers.