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FDA Watch: Approval for Sanofi, Merck & Co.; designation for BioXcel

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Dec. 28.


* Sanofi and Merck & Co. Inc.'s vaccine Vaxelis, to prevent diphtheria, tetanus, whooping cough, polio, hepatitis B and invasive disease due to Haemophilus influenzae type b in children from 6 weeks through 4 years of age.

* Horizon Pharma PLC's Ravicti, for infants younger than two months old with a urea cycle disorder. Ravicti is now approved for chronic management of urea cycle disorder in adults and children of all ages whose symptoms cannot be managed by avoiding eating protein or by supplementing with amino acids.

SNL Image
FDA headquarters in Silver Spring, Md.
Source: Associated Press

Priority review

* Acer Therapeutics Inc.'s Edsivo, for vascular Ehlers-Danlos syndrome in patients who have mutations in a protein called type 3 collagen.

Breakthrough therapy

* BioXcel Therapeutics Inc.'s BXCL501, for acute agitation due to medical and psychiatric conditions. BXCL501 is a film of dexmedetomidine that is placed under the tongue.