Actavis – FDA CRL

Actavis, L.L.C. received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA 208419) for Pemetrexed Injection 25 mg/mL, filed under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The application cannot be approved in its current form due to identified issues. A critical concern stems from deficiencies noted during a recent inspection of the Sindan-Pharma S.R.L. manufacturing facility; satisfactory resolution of these findings is mandatory. Additionally, the FDA requires a comprehensive safety update as per 21 CFR 314.50(d)(5)(vi)(b), which must detail any significant changes in the drug's safety profile, present retabulated safety data from all studies, and include worldwide safety experience. While specific comments on proposed labeling are reserved, Actavis is advised to prepare revised prescribing information conforming to FDA guidelines. The company must address all deficiencies and resubmit the application within one year under 21 CFR 314.110, or risk withdrawal. Actavis may also request a meeting with the FDA to discuss the necessary steps for approval. The drug product cannot be legally marketed until written approval is issued.