Elite Pharmaceuticals Inc (ELTP)

[Steges]

Elite will know approval status 3 business days via fax or secure email to the single regulatory point of contact at the company prior to the FDA publicizing the approval.

The FDA sends a copy of the signed approval or tentative approval letter, with any enclosures and confirms receipt of the letter.

If a press communication has been prepared the FDA press office will be notified as soon as receipt of the approval letter has been confirmed by the applicant.

Within one business day of approval, the FDA will issue an e-mail to the CDERAPPROVALS distribution list to notify appropriate personnel of the approval and the FDA Division of Online Communication (DOC) will publish on the FDA website on the following day,