Drug Industry Daily

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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.

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.

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).