Lupin Pharmaceuticals has gained FDA approval for its Norgestimate and Ethinyl Estradiol tablets, 0.18mg/0.025mg, 0.215mg/0.025mg, and 0.25mg/0.025mg.
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.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/lupin-wins-fda-approval-for-norgestimate-and-ethinyl-estradiol-tablets-040712
