Pharmaceutical Business review

Lupin wins FDA approval for Norgestimate and Ethinyl Estradiol tablets

Norgestimate and Ethinyl Estradiol tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

Lupin’s Norgestimate and Ethinyl Estradiol tablets are the AB-rated generic equivalent of Janssen Pharmaceuticals’ Ortho Tri-cyclen Lo tablets, 0.18mg/0.025mg, 0.215mg/0.025mg, and 0.25mg/0.025mg.

According to IMS Health sales data, Ortho Tri-cyclen Lo tablets had annual US sales of approximately $421m for the twelve months ending March 2012.