Heron Therapeutics Inc. on Monday said it has filed for U.S. Food and Drug Administration approval of the expanded use of its Zynrelef local anesthetic for postoperative pain.
The San Diego biotechnology company said its application covers the use of Zynrelef in foot and ankle, small to medium open abdominal and lower extremity total joint arthroplasty surgical procedures.
Heron said it met with the FDA and reached an agreement with the agency on the content of the application without the need for additional clinical studies.
In May, the FDA approved Zynrelef for use with adults for soft-tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.
Heron said it also agreed with the FDA on the studies needed to support a broad soft-tissue and orthopedic approval of the drug. The company said the studies are already underway, and it plans to submit its next filing supplement in the second half of 2022.
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