Drug Industry Daily

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The FDA’s Anti-Infective Drugs Advisory Committee Friday recommended approval of GlaxoSmithKline’s (GSK) 40-mg/kg raxibacumab IV solution, with or without an antimicrobial, to treat adults infected in an airborne anthrax attack.

The FDA has approved new indications for Janssen Pharmaceuticals’ Xarelto to treat deep vein thrombosis (DVT) or pulmonary embolism (PE) and to reduce the risk of recurrent DVT and PE following initial treatment.

The FDA is pushing back its action goal dates for some drug, biologic and device applications by up to two days following the closure of FDA offices on Oct. 29 and 30 due to Hurricane Sandy.

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 GMP regulations following a February 2012 warning letter.

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