Teva Receives FDA Approval For Oral Contraceptive

Pharmaceutical firm Teva has received FDA approval for the Abbreviated New Drug Application (ANDA) to market Tri-Lo Sprintec, a generic version of Ortho McNeil Janssen’s oral contraceptive, Ortho Tri-Cyclen Lo.

Teva has been awarded a 180-day period of marketing, as it has filed the first ANDA containing a paragraph IV certification for this product.

Teva is currently involved in patent litigation concerning this product in the US District Court for the District of New Jersey. A trial date has not been set yet.

Teva develops, manufactures and markets generic and human pharmaceuticals, as well as active pharmaceutical ingredients. The company also manufactures animal health pharmaceutical products.