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Posimir FDA Approval History

Last updated by Judith Stewart, BPharm on March 4, 2021.

FDA Approved: Yes (First approved February 1, 2021)
Brand name: Posimir
Generic name: bupivacaine
Dosage form: Solution for Infiltration Use
Company: Durect Corporation
Treatment for: Post-Surgical Pain

Posimir (bupivacaine) is a sustained-release anamide local anesthetic formulation indicated for post-surgical pain reduction following arthroscopic subacromial decompression shoulder surgery.

  • Posimir is administered as a single dose into the subacromial space under direct arthroscopic arthroscopic visualization (used to confirm proper placement of the needle tip).
  • Post-surgical analgesia can last for up to 72 hours.
  • The Posimir product label carries a boxed warning that advises the risk of potential adverse embolic effects resulting from inadvertent intravascular injection. Posimir must not be injected intravascularly.
  • Common adverse reactions reported in shoulder surgery patients include dizziness, dysgeusia, dysuria, headache, hypoesthesia, paresthesia, tinnitus, and vomiting.

Development Timeline for Posimir

Feb  2, 2021Approval  FDA Approves Posimir (bupivacaine) for Post-Surgical Pain Reduction for up to 72 Hours Following Arthroscopic Subacromial Decompression
Jan 17, 2020Durect Corporation Announces Outcome of FDA Advisory Committee Meeting for Posimir
Apr 16, 2013DURECT Announces Submission of New Drug Application for POSIDUR™ (SABER®-Bupivacaine)

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.