Generics

AMITYVILLE, N.Y. — Generic drug maker Hi-Tech Pharmacal said that it has acquired marketing and distribution rights to pain treatments made by Atley Pharmaceuticals.

Hi-Tech, which paid $3.6 million in cash for rights to the products and inventory, said some of Atley's drugs already have been approved by the Food and Drug Administration, while others were pending approval. The company didn't say which products it was acquiring the rights to, but noted that Hi-Tech subsidiary ECR Pharmaceuticals will produce and promote the products.

LIVINGSTON, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a drug designed to prevent premature birth in pregnant women.

Columbia Labs and Watson Pharmaceuticals announced Monday that the FDA would review their application for Prochieve (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the third trimester of pregnancy.

PITTSBURGH — A generic drug made by Mylan for Crohn’s disease does not infringe on the patent for the branded drug, a federal court ruled Thursday.

Mylan said the U.S. District Court for the District of Delaware ruled that Mylan’s regulatory approval application for budesonide capsules in the 3-mg strength does not violate the patent for the branded drug, AstraZeneca’s Entocort EC.

SALT LAKE CITY — Watson Pharmaceuticals plans to expand its manufacturing and research and development plant in Salt Lake City, the drug maker said.

The $44 million expansion of the plant will include retrofitting about 20,000 sq. ft. of space and the construction of about 17,000 additional sq. ft. The expansion of the plant, which makes transdermal patches and topical gels, is expected to include the addition of about 300 new employees over the next three to five years.

MUMBAI, India — Wockhardt has launched three new drugs in the United States over the last three weeks, the Indian generic drug maker said.

Wockhardt announced the Food and Drug Administration's approval and the launch of the company's antibacterial drug levofloxacin, a generic version of Johnson & Johnson’s Levaquin, in the 250-mg, 500-mg and 750-mg strengths.

WASHINGTON — The Supreme Court has struck down a law in Vermont designed to encourage generic drug usage by limiting the sharing of information about what branded drugs doctors prescribe, so that drug companies could use it when crafting sales pitches, according to published reports.

HYDERABAD, India — Generic drug maker Dr. Reddy’s Labs has launched its version of a popular antibiotic.

The company said its levofloxacin tablets in the 250-mg, 500-mg and 750-mg strengths have entered the market, following the Food and Drug Administration's approval of Dr. Reddy's abbreviated new drug application. Dr. Reddy's levofloxacin tablets in the 250-mg and 500-mg strengths are available in 50-count bottles, while the 750-mg strength bottle is available in 30-count bottles.

HAYWARD, Calif. — Impax Labs has expanded its senior management team with two appointments.

The generic drug maker said that Mark Fitch has joined the company as SVP operations, while Jeff Nornhold will become SVP quality affairs. Fitch, who joins Impax from Nycomed US, brings more than 35 years of pharmaceutical experience to his role. Nornhold, who most recently served as VP quality operations at drug maker Watson, is a 20-year pharmaceutical industry veteran.

Both Fitch and Nornhold will report to Impax president and CEO Larry Hsu.