Novartis Pays $100 Million for Mallinckrodt’s Priority Review Voucher
Novartis has paid $100 million for a Priority Review Voucher from Mallinckrodt that it will use to expedite the FDA’s review of an undisclosed product.
The agency awarded the voucher to Mallinckrodt as part of its approval of StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen — dsat) for treatment of adult patients with thermal burns.
The FDA issues the vouchers as an incentive to encourage the development of certain products that might not otherwise be commercially attractive. Voucher recipients may use them to accelerate a review of one of their own products or may sell them to another company.
The FDA aims to take action on a priority review application within six months, compared to 10 months for a standard review.