UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

 

FORM 8-K

 

 

CURRENT REPORT PURSUANT

TO SECTION 13 OR 15(D) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Date of report (Date of earliest event reported) January 22, 2008

 

 

NOVADEL PHARMA INC.

(Exact Name of Registrant as Specified in Its Charter)

 

 

Delaware

001-32177

22-2407152

(State or other jurisdiction of incorporation or organization)

(Commission File No.)

(I.R.S. Employer Identification No.)

 

 

25 Minneakoning Road

Flemington, New Jersey 08822

(Address of principal executive offices) (Zip Code)

 

(908) 782-3431

(Registrant’s telephone number, including area code)

 

N/A

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

 

o

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

 

Item 8.01. Other Events.

 

On January 23, 2008, NovaDel Pharma Inc. (“NovaDel”) announced that the U.S. Food and Drug Administration (“FDA”) has accepted for review the New Drug Application (“NDA”) for ZolpiMist™ (zolpidem tartrate) Oral Spray for the short-term treatment of insomnia. NovaDel anticipates the FDA will complete its review by the end of the year consistent with Prescription Drug User Fee Act (“PDUFA”) guidelines. The full text of the press release is set forth in Exhibit 99.1 hereto and incorporated herein.

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

 

NovaDel Pharma Inc.

 

 

By:

/s/ Michael E. Spicer

Name:

Michael E. Spicer

Title:

Chief Financial Officer

 

 

 

Date: January 24, 2008