The US Food and Drug Administration (FDA) has rejected United States-based Evolus' application seeking approval of DWP-450 intended to treat glabellar lines (frown lines) in adult patients, it was reported yesterday.
The regulator issued a complete response letter to the company, citing deficiencies regarding chemistry, manufacturing and controls processes. The company stated that that the FDA did not identify any deficiencies associated to clinical or non-clinical matters. The company's CEO, David Moatazedi, stated that the firm expects to respond to the concerns within 90 days.
DWP-450 (prabotulinumtoxinA) is a 900 kilodalton (kDa) purified botulinum toxin type A complex. The product candidate's marketing authorisation application is presently also under review by the European Medicines Agency (EMA).
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