Apotex’s Generic Approvals Delayed By FDA Paperwork Snafu, Lawsuit Says
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency’s “inexcusable delay” in granting final approval of Apotex’s ANDAs for Avapro and Avalide has caused the company to “fall fatally behind” in the marketplace now that 180-day exclusivity for the antihypertensive agents has expired, the manufacturer alleges.
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