Generics

PARSIPPANY, N.J. — Watson Pharmaceuticals is hoping to be the first to market a generic version of a GlaxoSmithKline drug for men with an enlarged prostate, Watson said.

Watson announced that it filed a regulatory approval application to market a generic version of GSK’s Jalyn (dutasteride and tamsulosin hydrochloride) capsules, a treatment for symptomatic benign prostatic hyperplasia in men with enlarged prostates.

ALLEGAN, Mich. — Perrigo on Thursday announced that it has received approval from the Food and Drug Administration to market a cinnamon-flavored, over-the-counter coated nicotine polacrilex gum USP in 2-mg and 4-mg strengths.

The product will be marketed under store-brand labels and is comparable with GlaxoSmithKline's Nicorette Cinnamon Surge coated gum, a stop-smoking aid.

PHILADELPHIA — The Food and Drug Administration has approved a drug for managing obesity made by Lannett.

Lannett announced the approval of phentermine hydrochloride capsules in the 37.5-mg strength, a generic version of Teva’s Adipex-P.

Phentermine hydrochloride capsules in the 37.5-mg strength had sales of about $8.8 million during the 12-month period ended in May, according to Wolters Kluwer.

AMITYVILLE, N.Y. — Hi-Tech Pharmacal has introduced levofloxacin oral solution in the 25-mg/mL strength, the drug maker said Tuesday.

The drug will be available in 480-mL, 200-mL and 100-mL sizes in order to allow pharmacists to tailor inventory to store volume. Hi-Tech was granted tentative approval in April.

The drug is a generic version of Johnson & Johnson’s pneumonia treament Levaquin.

PITTSBURGH — Generic drug maker Mylan is looking for a bigger place to call home, according to published reports.

The Pittsburgh Business Times reported that Mylan was planning to move from its current 96,000-sq.-ft. headquarters in Southpointe, a development in the Pittsburgh suburb of Cecil Township, to a 250,000-sq.-ft. building nearby.

The new headquarters is under construction, the newspaper reported.

WASHINGTON — New bipartisan legislation introduced to the Senate last week seeks to offer states incentives to use generic drugs by allowing states to temporarily keep a portion of the savings.

Senators Scott Brown, R-Mass.; Ron Wyden, D-Ore.; and John McCain, R-Ariz., introduced the Affordable Medicines Utilization Act of 2011, saying that the bill would encourage states to take advantage of cost-saving generic drugs.

GURGAON, India — Ranbaxy will produce and market three HIV/AIDS drugs that currently are in late-stage clinical development by Gilead under a new licensing agreement between the drug makers.

PITTSBURGH — Mylan subsidiary Matrix Labs has expanded its licensing agreement with Gilead Sciences.

Under the new terms, Mylan said that Matrix has the rights to produce and market generic versions of three Gilead HIV/AIDS therapies — elvitegravir, an investigational integrase inhibitor; cobicistat, an investigational antiretroviral boosting agent; and the “quad,” a once-daily, single-tablet combination of four separate Gilead medicines — if and when the drugs receive regulatory approval.