Regulatory and Washington

JERUSALEM — Teva Pharmaceutical Industries has filed a citizen petition with the Food and Drug Administration, hoping to keep purported generic versions of its multiple sclerosis treatment off the market, the company said Sunday.

Teva said its petition, concerning the drug Copaxone (glatiramer acetate), is based on what it called the inability to establish acceptable “sameness” due to the active ingredient’s complexity.

DUBLIN — Drug maker Shire has filed a patent infringement suit against Watson Pharmaceuticals and Impax Labs in response to their attempt to win approval from the Food and Drug Administration for a generic version of a Shire drug.

Shire announced that it had filed the suit in the U.S. District Court for the Northern District of California following the two generic drug makers’ filing of an approval application for guanfacine hydrochloride, a version of Shire’s Intuniv, used to treat hypertension.

SILVER SPRING, Md. — The Food and Drug Administration on Friday warned consumers not to use Man Up Now capsules, which are marketed as a dietary supplement for sexual enhancement, because they contain a variation of an active drug ingredient found in Viagra that can dangerously lower blood pressure.

PITTSBURGH — The Food and Drug Administration has approved a generic drug for hypertension made by Mylan.

Mylan announced Friday the approval of nifedipine extended-release tablets in the 30-mg, 60-mg and 90-mg strengths. The drug is a generic version of Bayer’s Adalat CC.

Nifedipine tablets had sales of around $82 million during the 12-month period ended in June, according to IMS Health.

FORT WASHINGTON, Pa. — McNeil Consumer Healthcare on Thursday voluntarily recalled all lots of Rolaids Extra Strength Softchews, Rolaids Extra Strength Plus Gas Softchews and Rolaids Multisymptom Plus Antigas Softchews distributed in the United States. McNeil is taking this action following some consumer reports of foreign materials in the product, including metal and wood particles.

SAN DIEGO — A Food and Drug Administration advisory committee has recommended approval for an investigational diet pill.

Orexigen Therapeutics and Takeda Pharmaceutical announced Tuesday that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13-7 that clinical trial data demonstrated that the benefits of the drug Contrave (naltrexone and bupropion) outweighed its risk and supported approval. The committee also voted 11-8 to recommend a study to examine Contrave’s effect on risk for cardiac disease.

ALEXANDRIA, Va. — Simplify, simplify.


ALEXANDRIA, Va., and WASHINGTON — The war of words between independent pharmacies and the pharmacy benefit management industry again is heating up. And again, the two groups are at odds over the question of how transparent — or opaque — the PBM industry’s business dealings with its clients are, and whether those business practices demand reform.