Glenmark gets USFDA nod for generic contraceptive tablets

Glenmark Pharmaceuticals has received approval from the US health regulator for generic Ashlyna contraceptive tablets and launched them in the American market.

Glenmark Generics Inc, USA, a subsidiary of Glenmark Generics, today announced the US market approval and introduction of Ashlyna extended-cycle oral contraceptive tablets, Glenmark Pharmaceuticals said in a statement.

The tablets are generic equivalent of Teva Women's Health's Seasonique tablets.

"According to IMS Health sales data for the 12 month period ending December 2014, the Seasonique market achieved annual sales of approximately USD 159.1 million," Glenmark said.

Today's approval marks the company's tenth oral contraceptive and first extended-cycle oral contraceptive authorised for distribution by the US Food and Drug Administration (USFDA), it added.

The company plans to commence shipping of Ashlyna immediately, Glenmark said.

Current portfolio of the company consists of 94 products authorised for distribution in the US and 75 ANDA's pending approval with the US health regulator, it added.

Glenmark Pharmaceuticals' shares were trading 0.77% down at Rs 801.20 apiece during afternoon session on the BSE.