Generic Line

Generic-drug makers, including those with backlogged ANDAs and companies submitting prior approval supplements (PASs) and drug master files (DMFs), will know by the end of October how much user fee money they’ll have to dole out to the FDA in fiscal 2013.

Drugmakers operating in the Third Circuit Court of Appeals jurisdiction will need to remain cautious about engaging in reverse patent settlements as the court refused to put on hold its recent ruling that such deals are anticompetitive while Merck and Upsher-Smith appeal to the Supreme Court.

Generic-drug makers have until Sept. 28 to either withdraw pending ANDAs or face a backlog fee, the FDA says.

Hospira is recalling another lot of hydromorphone HCl injection after receiving fresh reports of overfills in the syringe-based drug delivery system.

Watson Pharmaceuticals is suing the FDA after it failed to grant the company shared exclusivity on a generic of Type 2 diabetes drug Actos.

Patent settlements that involve a branded company’s commitment to not launch an authorized generic (AG) in competition with a generic company (no-AG agreements) are “without a doubt” anticompetitive pay-for-delay deals even though no cash payments are involved, the FTC says in an amicus brief.

Ranbaxy has withdrawn its approved ANDAs for 27 U.S. drugs to focus on other applications and fixing good manufacturing practice deviations that prompted a consent decree earlier this year.

Mylan is launching a generic version of sleep disorder drug Provigil after receiving FDA approval of the follow-on treatment and resolving its tumultuous first-filer fight with Teva.