USFDA gives nod for generic birth control pills

The Ethinyl estradiol and norethindrone combination is used to prevent pregnancy and is a birth control pill that contains two types of hormones.

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USFDA Approval
USFDA Approval

Last Updated on October 11, 2024 by The Health Master

Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the United States Food & Drug Administration (USFDA) for norethindrone acetate and Ethinyl estradiol capsules and ferrous fumarate capsules, 1 mg/20 mcg, the generic version of Taytulla capsules, from Allergan Pharmaceuticals International Limited.

The Ethinyl estradiol and norethindrone combination is used to prevent pregnancy and is a birth control pill that contains two types of hormones.

According to IQVIA sales data for the 12-month period ending May 2022, the Taytulla capsules market achieved annual sales of approximately $85.9 million.

Glenmark’s current portfolio consists of 177 products authorized for distribution in the US marketplace and 47 ANDA’s pending approval with the USFDA.

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 Pharmaceuticals Ltd. is an innovation-driven global pharmaceutical company with a presence across specialty, generics, and OTC businesses.

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