Connetics' acne treatment Velac (clindamycin/tretinoin) is "not approvable" at FDA due to dermal carcinogenicity concerns, the company said June 13.

FDA issued a not approvable letter on June 10; the user fee deadline was June 25.

The company said the only issue raised in the agency's letter was a positive carcinogenicity signal found in a dermal carcinogenicity study involving genetically altered mice.

Connetics said it is disappointed in the agency's decision but is confident that the issue can be resolved without conducting a new preclinical study.

FDA first notified Connetics about concerns relating to the mouse carcinogenicity study in April, the company said.

"We were particularly disappointed that FDA did not notify us of this as a potential issue until two months prior to the PDUFA date," the company said.

Connetics submitted additional information to FDA in April but had no indication that the agency would issue a not approvable letter ahead of the user fee date, the company said.

Velac combines 1% clindamycin with 0.025% tretinoin.

The company said it planned to immediately request a meeting with agency officials to resolve the outstanding issue as quickly as possible.

- Meg LaPorte

Connetics’ Velac Is “Not Approvable” For Acne

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