Glenmark gets FDA OK for three drugs

MUMBAI, India — The Food and Drug Administration approved three drugs made by Glenmark Generics last month and gave tentative approval to a fourth, the Indian generic drug maker said.

On Dec. 23, the company announced the approval of the arthritis treatment indomethacin in the 25-mg and 50-mg strengths; sales for the drug were $20 million during the 12-month period ended in September 2010, according to IMS Health. The agency also approved sulfamethoxazole and trimethorprim double- and single-strength tablets, used to treat chronic bronchitis, bacterial infections and other conditions; sales for the drug were $31 million, according to IMS.

In addition, the FDA granted tentative approval for eszopiclone, a generic version of Sepracor’s insomnia treatment Lunesta, which had sales of $760 million, according to IMS. Tentative approval means that a generic drug meets the FDA’s conditions for approval, but the agency must wait to grant final approval until the branded drug loses patent protection.

On Dec. 28, the agency approved the company’s lithium carbonate extended-release tablets in the 300-mg strength. A generic version of Noven Therapeutics’ Lithobid, the drug is used to treat manic episodes in patients with bipolar disorder. Total sales for the drug were $21 million during the 12-month period ended in September 2010, according to IMS.