Lupin Gets USFDA Final Nod for Contraceptive Drug | CORPORATE ETHOS

Lupin Gets USFDA Final Nod for Contraceptive Drug

By: | June 14, 2018
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Jun 14: Mumbai-based pharma major Lupin Ltd on Thursday 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 (USFDA).

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.

According to the company, the product 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 $82.2 million in the US (IQVIA MAT April 2018).

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