Indian pharmaceutical
multinational Lupin on November 4, 2022, announced that it has received
tentative approval from the United States Food and Drug Administration
(USFDA) 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 in birth control pills to prevent pregnancy and in menopausal hormone therapy, among other uses and is sometimes referred to as a "fourth-generation" progestin.Along with being used as a progestogen-only birth control pill, Drospirenone, in combination with the estrogens ethinylestradiol or estetrol, with or without supplemental folic acid, finds application as a combined birth control pill, and in combination with the estrogen estradiol for use in menopausal hormone therapy.The drug with low-dose ethinylestradiol is also indicated for the treatment of moderate acne, premenstrual syndrome, premenstrual dysphoric disorder, and painful menstruation.The company further informed quoting the IQVA MAT report of September 2022, that Slynd had estimated annual sales of 141 million dollars in the United States.
