Content about United States Public Health Service

NEW YORK — The director of the Food and Drug Administration's Office of Generic Drugs is stepping down, according to published reports.

Pharmalot, a blog run by journalist Ed Silverman, reported that Greg Geba is leaving the office over differences resulting from a recent reorganization, effective Friday.

SILVER SPRING, Md. — The Food and Drug Administration and the Federal Trade Commission last week issued a number of warning letters to distributors of "unapproved medicines," noting that because each of the products identified claimed to prevent or treat the cold or flu, they need to be registered and approved by the FDA. And because none of the ingredients listed are in fact monographed OTC cough, cold or flu symptom relievers, those products would additionally need to be filed as "new drugs."

NEW YORK — Drug maker Merz Pharmaceuticals is suing Par Pharmaceutical over the latter's attempt to market a generic drug for cerebral palsy patients, according to published reports.

Bloomberg reported that Merz sued Par in the U.S. District Court for the District of Delaware after Par attempted to apply for Food and Drug Administration approval for a generic version of Cuvposa (glycopyrrolate) oral solution, used to treat severe drooling in cerebral palsy patients.

The drug received FDA approval this year, and Merz bought rights to the drug in August.

SILVER SPRING, Md. — The Food and Drug Administration on Monday issued a warning letter to The Avalon Effect, a company based in Franklin, Tenn., for its marketing of a light therapy product that claims to cure or treat symptoms of fungal meningitis, methicillin-resistant Staphylococcus aureus, concussions, Lyme disease and other diseases.

SILVER SPRING, Md. — The Food and Drug Administration has declined to approve a drug developed by United Therapeutics Corp. for treating a potentially lethal high blood pressure condition.

The drug maker said it received a complete response letter from the agency for its application for a tablet formulation of the drug treprostinil. The company already markets the drug in injectable and inhaled formulations for pulmonary arterial hypertension, or PAH, a condition that causes high blood pressure in the arteries of the lungs.

SILVER SPRING, M.D. — The Food and Drug Administration may be willing to speed up trials for drugs that could be a big benefit to society despite their risks.

According to several published reports, FDA commissioner Margaret Hamburg recently told a group of scientific advisers that the agency is considering allowing makers of drugs having a societal benefit to conduct faster clinical trials with a smaller group of patients than is now required.

SILVER SPRING, Md. — The Food and Drug Administration on Thursday issued warning letters to PruTect Rx, of Highlands Ranch, Colo., and Trinity Sports Group, of Plano, Texas, for promoting products labeled as dietary supplements with claims to treat concussions and prevent or treat post-concussion syndrome and other neurological disorders.