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Heron Overcomes Two CRLs To Win Zynrelef Approval In Post-Op Pain

 
• By Joseph Haas

The combination of bupivacaine and meloxicam will be priced at a discount to Exparel, with Heron predicting rapid uptake. Label limited to three surgery types, but analysts expect off-label use.

FDA Approved typed words on a vintage typewriter
After two CRLs, Heron obtains US approval of its combo therapy for post-surgical pain

Heron Therapeutics, Inc. won US Food and Drug Administration approval – after two prior attempts – on 13 May for its post-operative pain drug Zynrelef (bupivacaine and meloxicam). The company intends to take significant market share by instituting competitive pricing and by expanding its existing sales team that already has experience and contacts in the hospital setting.

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