Teva Receives FDA Approval For Oral Contraceptive
Tri-Lo Sprintec is a generic version of Ortho McNeil Janssen's oral contraceptive, Ortho Tri-Cyclen Lo
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.
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