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.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.