FDA Calendar

Company Name Mallinckrodt plc
Drug Name StrataGraft (BLA)
Event Name FDA decision on StrataGraft for the treatment of adult patients with deep partial-thickness thermal burns.
Event Date 02/02/2021
Outcome Date
Drug Status The FDA granted StrataGraft skin tissue orphan drug designation, and it was among the first products designated by the Agency as a Regenerative Medicine Advanced Therapy (RMAT) under the provisions of the 21st Century Cures Act.
Rival Drugs
Market Potential
Other Approvals
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