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