Elite Pharmaceuticals Inc (ELTP)

[Steges]

This is very good news for Elite. Perhaps the best in years. What should not be overlooked is that while the lifting of the warning letter is important, the 12/4 pre-approval inspection is far more significant. A pre-approval inspection is performed to contribute to FDA’s assurance that a manufacturing establishment named in a drug application is capable of manufacturing a drug, and that submitted data are accurate and complete. It is the final step before an approval of an application.

Elite currently has five generic products pending FDA approval.

-Oxycodone Hydrochloride ER with ADT OxyContin ADT
-Oxycodone Hydrochloride and Acetaminophen, Percocet
-Hydrocodone Bitartrate and Acetaminophen, Norco
-Undisclosed Generic Undisclosed - Pain
-Undisclosed Generic Undisclosed - Bariatric

The inspection was classified as “No Action Indicated” (NAI).

https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/ucm073059.htm

NAI - No Action Indicated. No objectionable conditions or practices were found during the inspection.

We should be seeing an imminent approval of one of these filings.