FDAnews Drug Daily Bulletin

Depomed is taking the FDA to court, claiming the agency violated federal laws and its own regulations when it denied the company’s orphan drug Gralise seven years of marketing exclusivity.

Environmental monitoring programs, increasingly under scrutiny by FDA investigators, require continuous, top-level oversight and procedural accuracy to be effective, compliance experts say.

Fercy Personal Care Products, a Chinese OTC drugmaker, has been warned for a host of quality problems at its Jinhua, China, facility and for limiting investigators’ access to the unregistered plant.

The United States can double the number of innovative new medical treatments available in the next 10 or 15 years, but only if important changes are made to how drugs are developed and approved, according to a White House report.

GlaxoSmithKline and Theravance announced the FDA acceptance of the NDA for the once-daily investigational medicine fluticasone furoate for patients with chronic obstructive pulmonary disease or COPD, thereby indicating that the application is sufficiently complete to permit a substantive review.

Boehringer Ingelheim announced that clinical trial enrollment has completed for two Phase III studies evaluating the safety and efficacy of nintedanib (BIBF 1120), an investigational compound, in patients with idiopathic pulmonary fibrosis, being studied at a twice-daily oral dose.

Impax Laboratories announced that it and Teva Pharmaceuticals have reached agreement with Janssen Pharmaceuticals and ALZA to settle pending U.S. litigation with regard to the production and sale of generic formulations of Concerta (methylphenidate hydrochloride extended release tablets, 18 mg, 27 mg, 36 mg and 54 mg).

Turning in unused medicine is the best way for the public to safely dispose of unneeded pharmaceuticals.

Sanofi, France’s biggest drugmaker, said it may eliminate as many as 900 jobs in three years as part of a strategy to trim operations in its home market.