Lupin Limited 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.
Drospirenone is a progestin medication which is used as contraceptive to prevent pregnancy and in menopausal hormone therapy, among other uses.
It is available both alone under the brand name Slynd and in combination with an estrogen under the brand name Yasmin. The medication is taken by mouth.
Drospirenone Tablets (RLD Slynd) had estimated annual sales of USD 141 million in the U.S. (IQVIA MAT September 2022).
