Skip to main content

Regulatory and Washington

  • FDA approves Perrigo, Cobrek scalp psoriasis treatment

    ALLEGAN, Mich. — The Food and Drug Administration has approved a drug from Perrigo and Cobrek Pharmaceuticals for treating scalp conditions.

    Perrigo said that Cobrek, with which it is partnering, had received approval for betamethasone validate foam in the 0.12% strength. The drug is a generic version of Luxiq foam, made by GlaxoSmithKline subsidiary Stiefel Labs, and is used to treat corticosteroid-responsive skin conditions of the scalp, also known as scalp psoriasis.

    The branded version of the drug has annual sales of about $40 million, according to Perrigo.

  • Wockhardt receives three FDA approvals

    SILVER SPRING, Md. — Indian generic drug maker Wockhardt received three new drug approvals from the Food and Drug Administration, agency records show.

  • Ranbaxy recalls several lots of generic Lipitor

    NEW YORK — Ranbaxy Labs has recalled more than three dozen lots of its generic version of a cholesterol-lowering statin drug due to the possible presence of foreign particles, the company said.

  • Study: Health insurance plans not providing smoking cessation therapy pursuant to Affordable Care Act

    WASHINGTON — Many health insurance plans are failing to provide coverage mandated by the healthcare reform law for treatments to help smokers and other tobacco users quit, the Campaign for Tobacco-Free Kids reported Monday, citing a study of insurance contracts by Georgetown University researchers that the group commissioned. 

  • Fiscal cliff could hit retailers hard, White House report predicts

    WASHINGTON — Consumer spending could drop by almost $200 billion next year while depressing real consumer-spending growth by 1.7% if middle-class taxes rise in response to the fiscal cliff, according to a report released Monday by a White House economic team.

  • FDA approves first flu vaccine manufactured by Novartis using cell culture technology

    SILVER SPRING, Md. — The Food and Drug Administration on Wednesday announced the approval of Novartis' Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs. Flucelvax is approved to prevent seasonal influenza in people ages 18 years and older.

  • Walgreens urges Congress to resolve fiscal cliff

    DEERFIELD, Ill. — Walgreens on Tuesday publicly urged congressional leaders to make headway in avoiding the upcoming fiscal cliff if expiring tax cuts aren't reinstated. 

  • Minnesota company barred from going to market for violations of drug and dietary supplement regs

    SILVER SPRING, Md. — Pharmacist’s Ultimate Health of St. Paul, Minn., and its president, Stephen J. Poindexter, have been barred from distributing any "unapproved new drugs" that the company had distributed under the guise that they were dietary supplements. 

    The consent decree of permanent injunction that had been sought by the Food and Drug Administration was signed by U.S. District Judge David Doty of the U.S. District Court for the District of Minnesota on Nov. 6. 

X
This ad will auto-close in 10 seconds