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.
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