Glenmark gets US nod for generic contraceptives

Drug firm Glenmark Generics, US, a subsidiary of Glenmakr Generics Ltd today annoucned that it has receieved approval for the their abbreviated new drug application (ANDA) by the US health regulator United State Food and Drug Administration (USFDA) for their Norgestimate and Ethinyl Estradiol tablets -- a generic version of contraceptives.

The drug is the generic version of Ortho Cyclen tablets by Janssen Pharmaceuticals indicated for the prevenion of pregnancy in women who choose to use oral contraceptives for contraception.

This is Glenmark's tenth female hormonal product authorised for distribution by the USFDA.

According to IMS Health for the 12-month periodending December 2011, Norgestimate and Ethinyl Estradiol tablets garnered total market sales of $88 million.

The company's portfolio currently includes 79 products authorised for distribution in the US market and 39 ANDAs filed with USFDA pending for approval.

 

Shares of Glenmark Pharmaceuticals were today trading at Rs 307.40 in the morning trade on BSE, down 0.47% from its previous close.