FDAnews Drug Daily Bulletin

The FDA has agreed with Teva Parenteral Medicines’ position that the company is entitled to 180-day exclusivity for generic Kytril 1-mg/1-mL single-dose vials.

In a decision posted on its website, the FDA said Teva did not forfeit its exclusivity period by triggering certain provisions of the Medicare Modernization Act (MMA).

Roche’s Kytril (granisetron HCl) is indicated for preventing nausea and vomiting associated with cancer chemotherapy and radiation. Teva submitted its abbreviated new drug application for generic Kytril injection in May 2004 with a Paragraph III certification for Roche’s ’808 patent, which expired last month, and a Paragraph IV certification for the ’548 patent, which expires in 2019.

Teva sent the FDA a letter last fall asking the agency to confirm that it would indeed have exclusivity upon receiving final approval. The company argued that it had not met the MMA’s exclusivity forfeiture provisions, noting that the provisions serve to prevent first filers from “parking” their exclusivity and delaying generic entry.

The FDA’s response, along with Teva’s letter and the comments, is available at www.fda.gov/ohrms/dockets/DOCKETS/07n0389/07n0389.html.