USFDA tentatively approves Lupin’s birth control tablets | The Financial Express

USFDA tentatively approves Lupin’s birth control tablets

Drospirenone Tablets (RLD Slynd) had estimated annual sales of USD 141 million in the United States, as per IQVIA MAT September 2022.

USFDA tentatively approves Lupin’s birth control tablets
The drug will be available in one strength with a fixed dose to be taken once daily. (File)

Global pharma major Lupin Limited on Friday announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Drospirenone Tablets, 4 mg, to market a generic equivalent of Slynd Tablets, 4 mg, of Exeltis USA Inc.

The drug Drospirenone prevents ovulation and pregnancy and it is also indicated to treat acne and premenstrual dysphoric disorder (PMDD). It is also indicated for menopausal hormone therapy.

According to reports, in 2020, a formulation of drospirenone with ethinylestradiol was the 145th most commonly prescribed medication in the United States, with more than 4 million prescriptions.

Drospirenone Tablets (RLD Slynd) had estimated annual sales of USD 141 million in the United States, as per IQVIA MAT September 2022.

ALSO READ | Lupin inks agreement to acquire two inhalation brands from Sunovion

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First published on: 07-11-2022 at 12:08 IST