FDA Approves Mallinckrodt Pharmaceuticals' StrataGraft®

Written on June 18, 2021

FDA Approves StrataGraft®, an allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat

Please join us in congratulating Mallinckrodt Pharmaceuticals on their U.S. FDA approval of StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat) for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns). StrataGraft is the first approved donor site-free alternative to autograft for this patient population.

About StrataGraft®

In the last two to three decades, there have been few advances in the treatment of severe burn wounds. The approval of StrataGraft represents an important advancement in the treatment of patients with deep partial-thickness burns and a significant milestone for the burn care community. 


Burn surgeons now have a new biologic treatment to eliminate or reduce the need for autografting to attain definitive closure of the majority of deep partial-thickness treated wounds. Autografting can lead to donor site complications, including pain, itching, increased risk of infection and scarring. We are grateful to the patients who participated in the StrataGraft clinical trials and the physicians and study investigators involved in the clinical development program who helped us achieve this milestone. This approval affirms our commitment to the burn community. 


This project was funded in part with $86 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), under contract HHSO100201500027 for Stratatech, a Mallinckrodt company, to develop StrataGraft. 


More information about this exciting news, including the data that supported this FDA approval, can be found in the press release here. Have questions? Please contact Mallinckrodt.

About Mallinckrodt

Mallinckrodt Pharmaceuticals is a global biopharmaceutical company focused on improving outcomes for underserved patients with severe and critical conditions. We are honored to have Mallinckrodt Pharmaceuticals as one of our Phoenix Partners!


StrataGraft® is an allogeneic cellularized scaffold product indicated for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns).


Contraindications : Do not use in patients with known allergies to murine collagen or products containing ingredients of bovine or porcine origin.

Warnings and Precautions : StrataGraft contains glycerin. Avoid glycerin in patients with known sensitivity (irritant reaction) to glycerin.

Severe hypersensitivity reactions may occur. Monitor for both early and late symptoms and signs of hypersensitivity reaction following StrataGraft application, and treat according to standard medical practice.

StrataGraft contains cells from human donors and may transmit infectious diseases or infectious agents, eg, viruses, bacteria, or other pathogens, including the agent that causes transmissible spongiform encephalopathy (TSE, also known as Creutzfeldt-Jakob disease [CJD or variant CJD]).

StrataGraft is a xenotransplantation product because of an historic exposure of the keratinocyte cells to well-characterized mouse cells. The cell banks have been tested and found to be free of detectable adventitious agents, and mouse cells are not used in the manufacture of StrataGraft; however, these measures do not entirely eliminate the risk of transmitting infectious diseases and disease agents.

Transmission of infectious diseases or agents by StrataGraft has not been reported.

Because StrataGraft is a xenotransplantation product, StrataGraft recipients should not donate whole blood, blood components, plasma, leukocytes, tissues, breast milk, ova, sperm, or other body parts for use in humans.

Adverse Reactions : The most common adverse reactions (incidence ≥2%) were itching (pruritus), blisters, hypertrophic scar, and impaired healing. Other adverse events reported are included in the full Prescribing Information.

Pediatric Use : The safety and effectiveness of StrataGraft in pediatric patients (<18 years) have not been established.