Washington Drug Letter

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 Wednesday.

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

New England Compounding Center (NECC), the compounder blamed for an outbreak of fungal meningitis, violated state pharmacy law by acting as a bulk manufacturer and distributor of sterile drug products without proper registration, a preliminary investigation report states.

CDER plans to standardize REMS development to make the safety tools more effective and less burdensome for drugmakers.

The FDA’s plan to require more stability data for ANDAs is likely to slow approvals unless the agency flexes a little, generic-drug makers say.

The FDA has extended the PDUFA date for Biogen Idec’s multiple sclerosis (MS) treatment BG-12 by three months to March 28, 2013.

The FDA’s third annual review of backlogged postmarket requirements (PMR) and postmarket commitments (PMC) shows at least 58 percent of CDER’s reviews were fulfilled at the time of the most recent audit.

The FDA has given $2.7 million to University of Cincinnati researchers to study whether generic versions of the transplant drug Prograf have the same efficacy as Astellas Pharma’s branded product.

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

The FDA has approved Eli Lilly’s Alimta for use as a single agent for continuous maintenance treatment of nonsquamous non-small cell lung cancer (NS NSCLC) based on new clinical data.

United Therapeutics (UT) is hoping to get some answers from an end-of-review meeting on why the FDA rejected its oral treprostinil diethanolamine extended-release tablets for pulmonary arterial hypertension (PAH).

The FDA has approved Supernus Pharmaceuticals’ Oxtellar XR as a once-daily therapy for epilepsy and the company plans to launch the drug next year. 

The FDA has approved Eisai’s Fycompa tablets to treat partial-onset seizures in epilepsy patients ages 12 and older.

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.

Amgen and Novartis want the FDA to clarify which compounds would require an assessment of suicidal thoughts and behaviors under draft guidance the agency issued in August.