FDA Approvals, Highlights, and Summaries: Surgery and Postsurgical Analgesia

February 17, 2022

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

Seglentis ( celecoxib/tramadol) - New combination product indicated for management of acute pain in adults that requires opioid analgesic and for which alternative treatments are inadequate.

Zynrelef (bupivacaine/meloxicam ) - Long-acting nonopioid for noninjectable, local, postsurgical analgesia. Indicated as a single dose for postsurgical analgesia for up to 72 hours after foot and ankle surgery (eg, bunionectomy), small-to-medium open abdominal procedures (eg, open inguinal herniorrhaphy), or lower-extremity total joint arthroplasty surgical procedures (eg, 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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