Replies to post #387891 on Elite Pharmaceuticals Inc (ELTP)

[Omegaguy567]

Good to know, thanks!

[The ELTP King]

Nasrat was right on both statements during the past two CCs.

1. Intas invalidating some of Purdue's patents are completely irrelevant for the 180-day exclusivity.

2. The "substantially complete" ANDA application filing begins the PDUFA date, NOT when the FDA formally accepts the application.

- "With respect to 180-day generic drug exclusivity , we note that Roxane was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Sodium Oxybate Oral Solution, 500 mg/mL."