Regulatory and Washington

HAYWARD, Calif. — The Food and Drug Administration has found manufacturing issues at a plant owned by generic drug maker Impax Labs, the drug maker said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a dozen new generic versions of a drug used to treat breast cancer, the agency said Monday.

The FDA said that on Friday it approved versions of Novartis’ drug Femara (letrozole) made by Teva Pharmaceuticals USA, Dr. Reddy’s Labs, Sun Pharmaceutical Industries, Impax Labs, Endo Pharmaceuticals, Roxane Labs, Accord Healthcare, Synthon Pharmaceuticals, Natco Pharma, Indicus Pharma, Fresenius Kabi Oncology and Kudco Ireland.

PARSIPPANY, N.J. — Generic drug maker Watson Labs is hoping to market a generic version of a Pfizer drug for erectile dysfunction.

Watson announced Thursday that it had filed a regulatory approval application with the Food and Drug Administration to market a generic version of Viagra (sildenafil citrate) tablets in 25-mg, 50-mg and 100-mg strengths.

SILVER SPRING, Md. — The Food and Drug Administration has seized elderberry juice products that have been distributed by Wyldewood Cellars.

The FDA said that the products were seized from the Peck, Kan.-based company because they were unapproved, misbranded drugs that violated the agency's Federal Food, Drug and Cosmetic Act by stating that elderberry juice concentrate cures, treats or prevents various disease conditions, including AIDS, diabetes and flu.

The complaint was filed on May 27 in the U.S. District Court of Kansas.

WASHINGTON — The Centers for Disease Control and Prevention said that the Food and Drug Administration has recommended that the flu vaccine for the 2011-2012 season protect against the same strains as it did this year.

The FDA's Vaccines and Related Biological Products Advisory Committee recommended that the vaccine will protect those immunized against H1N1, H3N2 and a type of influenza-B virus, the same formulation as this past season's vaccine.

HAYWARD, Calif. — Pfizer has filed suit against generic drug maker Impax Labs in connection with the latter’s attempt to market a generic drug for bladder problems.

Impax said Friday that Pfizer filed a patent infringement suit in the U.S. District Court of the District of New Jersey in connection with Impax’s attempt to market a generic version of Detrol (tolterodine tartrate) immediate-release tablets in the 1-mg and 2-mg strengths. The drug is used to treat overactive bladder and urinary incontinence.

NEW YORK — Legislation recently introduced in the Senate aims to address the issue of drug shortages.

The Preserving Access to Life-Saving Medications Act, introduced in February by Sen. Amy Klobuchar, D-Minn., would require drug manufacturers to inform the Food and Drug Administration when supplies of a drug may be running low, allowing the agency to inform hospitals and attempt to address shortages.

The bill currently has nine cosponsors and is under review by the Senate Committee on Health, Education, Labor and Pensions, according to congressional records.

JERUSALEM — The Food and Drug Administration has approved a generic drug for Alzheimer’s disease made by Teva Pharmaceutical Industries.

The FDA approved Teva’s donepezil hydrochloride tablets in the 5-mg and 10-mg strengths.

The drug is a generic version of Aricept, made by Pfizer and Eisai. Branded and generic versions of the drug had sales of about $2.3 billion during the 12-month period ended in March, according to IMS Health.