The marketing application for INSYS Therapeutics' buprenorphine sublingual spray, being developed as a treatment for patients with moderate to severe acute pain, was accepted for review by the FDA. INSYS said the agency's action date of July 28, 2018, may be extended by three months if the FDA decides that the additional safety and tolerability data, to be submitted by the company in the next quarter, constitute a major amendment to the filing.
INSYS' acute pain drug accepted for FDA review
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