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July 1, 2009

Teva Oral Contraceptive Gets FDA Nod

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

By cms admin

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.

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