IntelGenx, Partner Get FDA Complete Response Letter for Buprenorphine Buccal Film
27 Abril 2023 - 9:47AM
Dow Jones News
By Robb M. Stewart
IntelGenx Corp. said Thursday its partner will address concerns
this quarter being raised by the U.S. Food and Drug Administration
in a complete response letter to an abbreviated new drug
application for Buprenorphine Buccal Film, a generic version of an
opioid used to manage chronic pain.
The Canadian drug-delivery company said co-developer Chemo
Research SL received the FDA's review of the data submitted in the
application, and the pair will contact the agency to discuss the
letter and assess the filing of a request for reconsideration of
the complete response letter.
Earlier this month, IntelGenx said the FDA approved the
company's Rizafilm new drug application for the treatment of acute
migraine.
Write to Robb M. Stewart at robb.stewart@wsj.com
(END) Dow Jones Newswires
April 27, 2023 08:32 ET (12:32 GMT)
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