FDA re­jects Re­vance's pitch for Botox com­peti­tor as biotech blames man­u­fac­tur­ing is­sues

The FDA has told Re­vance Ther­a­peu­tics that, no, it won’t be able to turn those frowns up­side down.

Reg­u­la­tors is­sued a CRL to the biotech for its botox-based ther­a­py for mod­er­ate to se­vere glabel­lar lines, al­so known as frown lines, Re­vance an­nounced Fri­day. As is agency pol­i­cy, the FDA does not com­ment on these types of com­mu­ni­ca­tions, but Re­vance said the re­jec­tion came from de­fi­cien­cies at a man­u­fac­tur­ing site.

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