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Teva Gains First Generic Zofran Injection Approval

This article was originally published in The Pink Sheet Daily

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Executive Summary

FDA approval comes roughly one month ahead of patent expiration for GSK's injectable antiemetic.

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Par Launches Generic Zofran ODT Following FDA Clearance

The agency also clears Dr. Reddy’s immediate-release ondansetron formulation which the Indian firm said it will launch shortly.

Par Launches Generic Zofran ODT Following FDA Clearance

The agency also clears Dr. Reddy’s immediate-release ondansetron formulation which the Indian firm said it will launch shortly.

Zofran Patent Ruling

Two method-of-use patents for GlaxoSmithKline's Zofran are valid and infringed by Teva's ANDA, Wilmington, Del. federal Judge Gregory Sleet ruled Aug. 20

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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