Generic Line

ANDA filers that have submitted an application on or after Oct. 1 must pay $51,520 in user fees, according to the FDA’s 2013 generic drug user fee rates announced Oct. 25.

A district court has ordered the FDA to immediately approve Watson’s ANDA for a generic of Takeda’s billion-dollar diabetes treatment Actos.

Teva Pharmaceuticals has resolved a long-outstanding warning letter for its Irvine, Calif., plant, the company said on its third-quarter earnings call Nov. 1.

The U.S. District Court for the District of New Jersey has ordered a stay on seven pay-for-delay cases against Wyeth and Teva involving Wyeth’s Effexor XR while the Supreme Court decides if it will review the legality of reverse patent settlements.

Par Pharmaceutical can launch a generic version of AstraZeneca’s extended-release antipsychotic Seroquel XR by November 2016 following its acquisition of Handa Pharmaceuticals’ ANDA.

Dr. Reddy’s plans to key in on more complex generics such as injectables, particularly in the U.S. market, to help insulate its products from fierce competition.

Hikma Pharmaceuticals will cease commercial production at its Eatontown, N.J., plant through mid-January to focus on bringing the facility back into compliance with good manufacturing practice regulations following a February 2012 warning letter.

A new bipartisan track and trace proposal floated by House and Senate lawmakers Oct. 24 would implement a uniform national policy on drug product tracing, heading off state-by-state initiatives.

Hetero can launch a generic version of Forest Laboratories’ hypertension drug Bystolic three months prior to the expiration of Forest’s exclusivity on Dec. 17, 2021, or on the date it receives final ANDA approval from the agency, whichever is later under the terms of a proposed settlement.

SEATTLE — The FDA’s Office of International Programs (OIP) is exploring development of a single, global recall system that would encompass all domestic and international recalls.

The FDA is working with manufacturers to ramp up production of six generic drugs after an Ameridose recall last week.

Impax Laboratories’ reliance on a few key products — two generics and one brand drug — for the bulk of its revenue is likely to hurt the company in the near future as it loses its near monopoly on the drugs.