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Glenmark receives consent for contraceptive drug from USFDA

Glenmark Pharmaceuticals has received final approval from the US health regulator, for a generic version of Loestrin tablets, which is used to prevent pregnancy.

In a BSE filing Glenmark stated, “Glenmark Pharmaceuticals USA has been granted final approval by the US Food and Drug Administration (USFDA) for Hailey Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol tablets USP, 1 mg/20 mcg and Ferrous Fumarate tablets), the generic version of Loestrin 1/20 Fe tablets, of Allergan Pharmaceuticals.”

Further, the company currently has a portfolio of 129 products authorized for distribution in US market andΒ 58 Abbreviated New Drug Applications (ANDA) pending for approval with the USFDA.

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