FDA Drug Approvals, Surgery and Postsurgical Analgesia — 2021 Midyear Review

August 20, 2021

StrataGraft (allogeneic cultured keratinocytes and fibroblasts)

Allogeneic cultured keratinocytes and fibroblasts is a biologic skin substitute for grafting deep partial-thickness burns. It is an allogeneic cellularized scaffold product containing metabolically active cells that produce and secrete a variety of growth factors and cytokines that are known to be involved in wound repair and regeneration.

Approval was based on the phase 3 STRATA2016 trial. Results showed that by 3-month follow-up, durable wound closure without the need for autografting had occurred at StrataGraft treatment sites in 59 (92%) of 64 patients. Burns. 2021 Apr 23; S0305-4179(21)00110-8

Other surgery and postsurgical analgesia approvals

Zynrelef (bupivacaine/meloxicam) - New combination approved for long-acting nonopioid, noninjectable, local, postsurgical analgesia. It is indicated as a single dose for postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty.

Exparel (bupivacaine liposomal) - New indication for postsurgical local analgesia expanded to include children aged 6 years and older.

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