Mylan launches generic oral contracepitve

CANONSBURG — Mylan N.V. said Tuesday it initiated the U.S. launch of Norgestimate and Ethinyl Estradiol Tablets USP, the generic version of Janssen’s Ortho Tri-Cyclen Lo Tablets.
Mylan said it received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for the product, which is indicated for the prevention of pregnancy.
Norgestimate and Ethinyl Estradiol Tablets had U.S. sales of approximately $488.6 million for the 12 months ending Sept. 30, according to IMS Health. The product represents Mylan’s 14th oral contraceptive launch in the U.S.