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FDA accepts Insys' NDA for buprenorphine sublingual spray

December 6, 2017 6:04 PM UTC

Insys Therapeutics Inc. (NASDAQ:INSY) said FDA accepted for review an NDA for the company’s buprenorphine sublingual spray to manage moderate to severe acute pain. The PDUFA date is July 28, 2018.

Next quarter, Insys said it plans to submit data from a recently completed seven-day safety and tolerability trial that is intended to expand the duration of exposure for the product. The company said the new data may affect the candidate's PDUFA date...

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Insys Therapeutics Inc.