Content about Food and Drug Administration

PITTSBURGH — The Food and Drug Administration has approved a generic malaria drug made by Mylan, the drug maker said Tuesday.

Mylan announced the approval of quinine sulfate capsules in the 324-mg strength and has begun shipping it. The drug is a generic version of Mutual Pharmaceutical's Qualaquin and is used to treat uncomplicated Plasmodium falciparum malaria.

Various versions of the drug had sales of about $31.9 million during the 12-month period ended in September 2012, according to IMS Health.

INDIANAPOLIS — More than two-thirds of generic drugs carry safety warning labels different from those of their branded equivalents, according to a new study.

LONDON — The Food and Drug Administration has approved a new biotech drug from GlaxoSmithKline for anthrax, the drug maker said.

GSK announced the approval of raxibacumab for adults and children who have inhaled Bacillus anthracis. The drug is designed for combination with antibiotics and for preventing inhalational anthrax when alternative therapies aren't available. The drug is the result of a project that Human Genome Sciences, now owned by GSK, began working on in 2001 in response to terrorist anthrax attacks in the United States.

PARSIPPANY, N.J. — The consumer products division of British drug maker GlaxoSmithKline wants its voice heard at a Food and Drug Administration hearing scheduled for next year on a section in a 2009 law to regulate tobacco products that deals with smoking-cessation products, the company said Monday.

WILMINGTON, Del. — A federal court has ruled in favor of AstraZeneca in a case regarding a cholesterol drug, the company said.

AstraZeneca said the Court of Appeals for the Federal Circuit upheld a decision by the U.S. District Court for the District of Delaware ruling that a patent covering the drug Crestor (rosuvastatin calcium) was valid and enforceable. The patent, which expires in 2016, covers the active ingredient of Crestor.

DEERFIELD, Ill. — The Food and Drug Administration has accepted a regulatory approval application from Takeda and Lundbeck for an experimental drug to treat depression, the companies said Wednesday.

The FDA will review the companies' application for vortioxetine for the treatment of major depressive disorder in adults. The agency expects to finish reviewing the application by Oct. 2, 2013.

MOUNT PROSPECT, Ill. — A national group representing state boards of pharmacy has announced its support for efforts to strengthen regulations on compounding pharmacies.

The National Association of Boards of Pharmacy said Wednesday that it would implement a four-part action plan centered around inspection of compounding pharmacies and sharing data from the inspections among boards of pharmacies around the country.

NEW YORK — The Supreme Court will review settlements between branded and generic drug companies that critics say delay patients' access to cheaper drug treatments, according to published reports.

Politico reported that the justices had agreed to hear three cases, including Federal Trade Commission v. Watson Pharmaceuticals, involving settlements between branded and generic drug companies that critics deride as "pay-for-delay" deals.

NORTHBROOK, Ill. — Astellas Pharma US announced the Food and Drug Administration's review of their new drug application for tacrolimus extended-release capsules, a once-daily formulation of the calcineurin-inhibitor immunosuppressant tacrolimus, for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients.

NEW YORK — A Congressional committee is looking into allegations that a compounding pharmacy industry association may have taught pharmacists how to sidestep requests for samples from the Food and Drug Administration, according to published reports.

Reuters reported that the House Energy and Commerce Committee had requested internal documents from the International Academy of Compounding Pharmacists, citing a news report about the organization.

PITTSBURGH — The Food and Drug Administration has approved a generic hypertension drug made by Mylan, the company said.

Mylan announced the approval and launch of candesartan cilexetil and hydrochlorothiazide tablets in the 16/12.5-mg, 32/12.5-mg and 32/25-mg strengths. Mylan said it was the first company to submit a complete regulatory approval application for the drug and is thus entitled to 180 days of market exclusivity in which to compete directly with the branded version.

HORSHAM, Pa. — Johnson & Johnson is seeking approval from the Food and Drug Administration for a drug to treat active psoriatic arthritis, the company said Thursday.

J&J subsidiary Janssen Biotech submitted an application to the FDA for Stelara (ustekinumab) for adult patients with the disease, which affects more than 2 million people in the United States, according to the National Psoriasis Foundation. Another subsidiary is seeking approval for Stelara for the same usage in Europe.