Lupin Pharmaceuticals has received final approval for its Drospirenone and Ethinyl Estradiol Tablets, 3 mg / 0.03 mg from the United States Food and Drugs Administration (US FDA) to market a generic version of Bayer Healthcare’s (Bayer) Yasmin tablets 3 mg / 0.03 mg.
Lupin’s Drospirenone and Ethinyl Estradiol tablets are the AB rated generic equivalent of Bayer’s Yasmin tablets 3 mg / 0.03 mg. Lupin’s Drospirenone and Ethinyl Estradiol tablets are a combined oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Lupin will be marketing its Drospirenone and Ethinyl Estradiol tablets USP in a wallet pack of 28 tablets consisting of 21 yellow active tablets, each containing 3 mg Drospirenone and 0.03 mg Ethinyl Estradiol, and seven white inert tablets.
Yasmin tablets had annual US sales of approximately $275.1 million.
EP News Bureau – Mumbai
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