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The Food and Drug Administration (FDA) has issued a priority review voucher to PTC Therapeutics Inc. for their product, KEBILIDI (eladocagene exuparvovec-tneq). This product is designed to treat both adult and pediatric patients with a condition known as aromatic L-amino acid decarboxylase deficiency. The priority review voucher is awarded under the Rare Pediatric Disease program, which encourages the development of treatments for rare diseases affecting children. The FDA is required to announce when such vouchers are given, as part of the criteria set by the Federal Food, Drug, and Cosmetic Act.

The Food and Drug Administration (FDA) is withdrawing the approval of 27 abbreviated new drug applications because the companies that made these drugs told the FDA that they are no longer selling them. The withdrawal means these drugs will no longer have permission to be sold in the market. This action will take effect on February 16, 2021, but any remaining drug inventory that is still compliant with regulations can be used up until it runs out or expires.