Washington Drug Letter

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.

The Office of Prescription Drug Promotion (OPDP) has placed developing social media guidance at the top of its work plan for 2013, Director Thomas Abrams says.

The FDA has hit International Laboratories Canada with a warning letter for good manufacturing practice (GMP) violations related to supplier qualification and the company’s quality control unit.

The DOJ is looking into Novartis’ relationship with Accredo Health Group, handing the specialty pharmacy company a subpoena on dealings related to iron overload drug Exjade (deferasirox).

The FDA’s lack of a policy or guidance to help API manufacturers deal with a new European directive on falsified medicines is causing concern among manufacturers about lost sales and drug shortages in Europe, an expert says.

A House Committee on Energy & Commerce subcommittee will question FDA Commissioner Margaret Hamburg at a Wednesday hearing on the recent fungal meningitis outbreak linked to a compounding pharmacy.

A 10-member FDA advisory panel voted unanimously Nov. 7 to recommend approval of Novartis’ Signifor for the treatment of Cushing’s disease.

The FDA has approved Pfizer’s Xeljanz as a second-line treatment for adults with moderately to severely active rheumatoid arthritis (RA) who didn’t respond to or cannot take methotrexate.

Hospira continues to remain at risk for a consent decree as negative manufacturing updates, additional Form 483 observations and product recalls pile up, one analyst says.

The FDA’s Anti-Infective Drugs Advisory Committee on Nov. 2 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.

FDA advisers voted 8–4 Thursday in support of approval for Novo Nordisk’s ultra-long acting insulin candidates Tresiba and Ryzodeg for Type 1 and Type 2 diabetes despite lingering worries about cardiovascular effects.

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.

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

The FDA has denied Public Citizen’s appeal for a ban on the 23-mg dose of Eisai’s Alzheimer’s drug Aricept.