Lupin’s Tablets Receives USFDA Approval

Pharma major Lupin announced that it has received final approval for its Drospirenone, Ethinyl Estradiol, Levomefolate Calcium Tablets, and Levomefolate Calcium Tablets, 3 mg/0.02 mg/0.451 mg and 0.451 mg, from the United States Food and Drug Administration (FDA) to market a generic version of Bayer HealthCare Pharmaceutical Inc.’s (Bayer) Beyaz Tablets. Lupin’s Drospirenone, Ethinyl Estradiol, Levomefolate Calcium Tablets, and Levomefolate Calcium Tablets, 3 mg/0.02 mg/0.451 mg and 0.451 mg, are the generic equivalent of Bayer’s Beyaz Tablets. It is indicated for use by women to:

• prevent pregnancy;
• treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception;
• treat moderate acne for women at least 14 years old, only if the patient desires an oral contraceptive for birth control; and
• raise folate levels in women who choose to use an oral contraceptive for contraception.

Drospirenone, Ethinyl Estradiol, Levomefolate Calcium Tablets, and Levomefolate Calcium Tablets, 3 mg/0.02 mg/0.451 mg and 0.451 mg had annual sales of approximately USD 82.2 million in the US (IQVIA MAT April 2018). – Medical Buyer Bureau