Ted White, Verrica CEO

Ver­ri­ca hits an­oth­er bump in the road with CMO re­lat­ed let­ter from FDA

The FDA has re­ject­ed Ver­ri­ca’s new drug ap­pli­ca­tion for VP-102 again, with the com­pa­ny pin­ning the CRL on prob­lems at a CMO that it was part­nered with, the com­pa­ny an­nounced Mon­day.

The FDA didn’t raise is­sues that di­rect­ly re­late to the man­u­fac­tur­ing of VP-102, the com­pa­ny said, but raised “gen­er­al qual­i­ty is­sues” at the CMO’s fa­cil­i­ty. There were al­so no clin­i­cal con­cerns, it said, or need to col­lect more da­ta.

Endpoints News

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.