Regulatory and Washington

SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a new drug for HIV made by an Indian company.

FDA records show that the agency gave tentative approval tablets and oral suspension that combine lamivudine, nevirapine and zidovudine in the 30-mg/50-mg/60-mg strength.

NEW YORK — An uptick in the use of cholesterol drugs since the late 1980s and changes in Americans' diets may account for a fall in cholesterol levels, according to a new study by the Centers for Disease Control and Prevention.

SILVER SPRING, Md. — The Food and Drug Administration has approved what it called the first drug to treat an eye condition that can interfere with the part of the retina responsible for reading vision.

The agency announced the approval of Jetrea (ocriplasmin), made by Iselin, N.J.-based ThromboGenics. The drug is used to treat symptomatic vitreomacular adhesion.

MUMBAI, India — The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said Thursday.

Lupin announced the approval of Kurvelo (levonorgestrel and ethinyl estradiol) tablets in the 0.15 mg/0.03 mg strength.

The drug is a generic version of Teva's branded Nordette. Nordette had sales of about $59 million during the 12-month period ended in June, according to IMS Health.

ROCHESTER, N.Y. — A company that makes health kiosks has joined a campaign to promote blood pressure management among patients with hypertension.

MENLO PARK, Calif. — The Food and Drug Administration has accepted a regulatory approval application for a drug for hot flashes from Depomed, the drug maker said.

Depomed submitted its application to the FDA for Serada (gabapentin), an extended-release drug for hot flashes in menopausal women.

ALLEGAN, Mich. — Perrigo has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application to market over-the-counter omeprazole and sodium bicarbonate capsules in the 20-mg/1,100-mg strength, the store-brand equivalent to Merck's Zegerid OTC.

Zegerid OTC (omeprazole and sodium bicarbonate capsules 20 mg/1,100 mg), a proton-pump inhibitor indicated to relieve frequent heartburn, had sales of approximately $42 million through food, drug and mass merchandisers for the lastest 12 months.

PARSIPPANY, N.J. – The Federal Trade Commission has voted to approve Watson Pharmaceutical's acquisition of Switzerland-based generic drug maker Actavis.

The unanimous vote in support of the merger follows Watson's agreement to divest a number of marketed and pipeline products to Par Pharmaceutical and Sandoz as a condition to obtaining FTC approval.