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Olinvyk FDA Approval History

FDA Approved: Yes (First approved August 7, 2020)
Brand name: Olinvyk
Generic name: oliceridine
Dosage form: Injection
Previous Name: Olinvo
Company: Trevena, Inc.
Treatment for: Pain

Olinvyk (oliceridine) is an opioid agonist for the management of moderate to severe acute pain in adults.

Development Timeline for Olinvyk

DateArticle
Aug 10, 2020Approval FDA Approves Olinvyk (oliceridine) Injection for the Management of Severe Acute Pain
Feb 10, 2020Trevena Resubmits New Drug Application for Oliceridine
Mar 11, 2019Trevena Announces Publication of APOLLO-1 Results in The Journal of Pain Research Highlighting Oliceridine’s Potential for Management of Moderate-to-Severe Acute Pain
Nov  2, 2018Trevena Receives Complete Response Letter for Oliceridine from FDA
Oct 11, 2018Trevena Announces Oliceridine FDA Advisory Committee Meeting Outcome
Jan  2, 2018Trevena Announces FDA Acceptance for Review of New Drug Application for Olinvo (oliceridine) Injection
Nov  2, 2017Trevena Announces Submission of New Drug Application to U.S. FDA for Olinvo (oliceridine injection)

Further information

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