New Delhi: Glenmark Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for generic Ashlyna contraceptive tablets and launched them in the American market.
New Delhi: Glenmark Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for generic Ashlyna contraceptive tablets and launched them in the American market.
Glenmark Generics Inc, USA, a subsidiary of Glenmark Generics, on Wednesday 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 $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 drug regulator (FDA), 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.
As of 2:07 p.m., shares in Glenmark were trading at Rs 799.75 apiece on the BSE, down 0.95 per cent from the previous close.
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