FDA accepts resubmission for omidenepag isopropyl, a proposed treatment for glaucoma and ocular hypertension.
Santen Pharmaceutical and Ube Industries said on 10 June 2022 that the FDA has accepted for review the resubmission of their jointly developed glaucoma and ocular hypertension drug omidenepag isopropyl following the agency’s rejection last year.
The target action date under the Prescription Drug User Fee Act (PDUFA) was set for 6 November 2022. Previously known with the development code of STN1011700/DE-117, the drug is sold under the brand name Eybelis in Japan.
The companies received a complete response letter (CRL) from the FDA last November, stating that the drug could not be approved at that time. In the letter, the regulator pointed out that although there were no issues deriving from the production of the drug itself, the contract manufacturing facilities did not comply with the cGMP. The new drug application was resubmitted upon confirming that all the FDA’s findings were addressed and it was accepted for review on 8 June 2022.
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