Content about Lactams

SILVER SPRING, Md. — The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said Thursday.

The FDA originally declined to approve the drug, treprostinil diolamine extended-release tablets, in a letter submitted to the company in October 2012.

The agency plans to decide whether or not to approve the drug in March of this year, United Therapeutics said.

NEW YORK — Drug maker Otsuka Pharmaceuticals can keep generic versions of its schizophrenia drug off the market, according to published reports.

Bloomberg reported that the Supreme Court upheld a ruling that allowed Otsuka to block Canadian generic drug maker Apotex from marketing a version of the antipsychotic Abilify (aripiprazole), which Otsuka co-markets with Bristol-Myers Squibb.

HYDERABAD, India — Dr. Reddy's Labs has launched a generic drug for treating baldness, the Indian drug maker said.

Dr. Reddy's announced the launch of finasteride tablets in the 1-mg strength, a generic version of Merck's Propecia. As the first company to successfully file for approval of a generic version of the drug, Dr. Reddy's is entitled to 180 days of market exclusivity in which to compete directly with the branded version.

Propecia had sales of about $136 million during the 12-month period that ended in October 2012, according to IMS Health.

SILVER SPRINGS, Md. — Teva Pharmaceuticals has received approval of their new drug application for topotecan hydrochloride injection, a treatment for small cell lung cancer, according to Food and Drug Administration records.

PITTSBURGH — The Food and Drug Administration has approved a generic drug made by Mylan for treating pulmonary arterial hypertension, the drug maker said Tuesday.

Mylan announced the FDA approval of sildenafil citrate tablets in the 20-mg strength, a generic version of Pfizer's Revatio. The drug is used to treat adults with PAH to improve exercise ability and delay clinical worsening of the condition.

Revatio had sales of about $339 million during the 12-month period ended in September, according to IMS Health.

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.

PITTSBURGH — Generic drug maker Mylan has received regulatory approval for a drug used to treat high blood pressure, also known as hypertension, the company said Friday, saying that it would launch both drugs immediately.

Mylan said the Food and Drug Administration approved its irbesartan tablets in the 75 mg, 150 mg and 300 mg strengths and irbesartan and hydrochlorothiazide tablets in the 150 mg/12.5 mg and 300 mg/12.5 mg strengths. The drugs are respectively generic versions of Sanofi's Avapro and Avalide.

PARSIPPANY, N.J. — Indian drug maker Wockhardt has received tentative approval from the Food and Drug Administration for a generic version of a Pfizer psychiatric drug.

Wockhardt announced the tentative approval for ziprasidone hydrochloride in the 20 mg, 40 mg, 60 mg and 80 mg strengths, used to treat bipolar disorder and schizophrenia, and the company plans to launch the drug on Sept. 2, 2012.

PEAPACK, N.J. — The generics division of drug maker Pfizer is recalling supplies of two drugs due to possible mislabeling.

Greenstone announced Saturday that it would voluntarily recall 100-count bottles of citalopram 10-mg tablets and 90-count bottles of finasteride 5-mg tablets with the lot number FI0510058-A on the label. The company said a third-party manufacturer may have placed incorrect labels on the bottles. No other lots are affected.

Citalopram is used to treat depression, while finasteride is used to treat benign prostatic hyperplasia.