Teva Oral Contraceptive Gets FDA Nod

1 July 2009 (Last Updated July 1st, 2009 18:30)

Teva Pharmaceutical has received US Food and Drug Administration (FDA) approval to market Tri-Lo Sprintec, a generic version of Ortho-McNeil-Janssen's oral contraceptive, Ortho Tri-Cyclen Lo. Teva had been awarded a 180-day period of marketing after filing an initial Abbreviated New Drug

Teva Pharmaceutical has received US Food and Drug Administration (FDA) approval to market Tri-Lo Sprintec, a generic version of Ortho-McNeil-Janssen's oral contraceptive, Ortho Tri-Cyclen Lo.

Teva had been awarded a 180-day period of marketing after filing an initial Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for the product.

Teva is currently involved in patent litigation concerning the product in the US District Court for the District of New Jersey.

A trial date has not been set yet.