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) June 2, 2005
NOVADEL
PHARMA INC.
(Exact
Name of Registrant as Specified in Its Charter)
|
Delaware |
|
001-32177 |
|
22-2407152 |
|
(State
or other jurisdiction
of
incorporation) |
|
(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):
|
¨ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425) |
|
¨ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12) |
|
¨ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b)) |
|
¨ |
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 June
2, 2005, NovaDel Pharma Inc. (the “Company”) issued a press release to announce
that the Company received an approvable letter from the U.S. Food and Drug
Administration regarding its New Drug Application (NDA) for
NitroMist™
(nitroglycerin lingual aerosol), indicated for acute relief of an attack or
acute prophylaxis of angina pectoris due to coronary artery disease. The full
text of the press release is set forth in Exhibit 99.1 hereto.
Item
9.01. Financial Statements and Exhibits.
(c)
Exhibits.
99.1.
Press release dated June 2, 2005, titled “NovaDel Pharma Receives Approvable
Letter from the FDA for NitroMist™
(nitroglycerin lingual aerosol).”
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. |
|
|
|
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By: |
/s/ Jean W. Frydman |
| |
Name: Jean W. Frydman |
| |
Title: Vice President and General
Counsel |
Date:
June 8, 2005
EXHIBIT
INDEX
Exhibit |
|
Description |
|
99.1 |
|
Press
release dated June
2, 2005, titled “NovaDel Pharma Receives Approvable Letter from the FDA
for NitroMist™
(nitroglycerin lingual aerosol).” |