Shares of Verrica Pharmaceuticals Inc. are lower in Monday's late-trading session, after the company said it received a complete response letter from the U.S. Food and Drug Administration identifying deficiencies at a contract manufacturer's facility for its VP-102.
The company said it filed a new drug application for VP-102 to treat molloscum contagiosum, a viral infection affecting the skin.
Verrica said the deficiencies identified by the FDA "are not specifically related to the manufacturing of VP-102 but instead raise general quality issues at the facility." The company added, "the FDA did not identify any clinical, safety or product specific chemistry, manufacturing, and controls deficiencies related to VP-102."
The contract manufacturing organization advised Verrica it is "expecting a satisfactory resolution of the facility's identified deficiencies from the FDA within the next 30 business days," Verrica said.
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