US FDA approves Glenmark's oral contraceptives

Glenmark Pharmaceuticals has received the final nod from the US health regulator for generic oral contraceptive norgestimate ethinyl estradiol tablets.

''Glenmark Pharmaceuticals Inc, USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (US FDA) for Norethindrone Acetate and Ethinyl Estradiol tablets USP, 1 mg/0.02 mg, the generic version of Loestrin 21 1/20 tablets of Warner Chilcott Company, LLC,'' the company stated in a BSE filing.

This will enable Glenmark Pharmaceuticals USA to market `norgestimate' and `ethinyl estradiol' tablets USP, 0.18 mg/0.025 mg, 0.215 mg/ 0.025 mg and 0.25 mg/0.025mg," the company stated, adding that the approval has been granted for generic version of Ortho Tri-cyclen Lo tablets of Janssen Pharmaceuticals, Inc.

According to IMS Health sales data for the 12 month period ending November 2015, the Loestrin 21 1/20 tablets market achieved annual sales of approximately $56.8 million.

Glenmark's current portfolio consists of 106 products authorised for distribution in the US marketplace and 62 ANDA's pending approval with the US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

Glenmark, meanwhile, said that cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.