NovaDel NDA for Nitroglycerin Lingual Spray is Accepted for
Review by FDA
Par Pharmaceutical Has Exclusive Rights To U.S. And Canada
FLEMINGTON, N.J., Sept. 29 /PRNewswire-FirstCall/ -- NovaDel Pharma Inc. (AMEX:NVD) today announced that the NDA for its aerosol nitroglycerin lingual
spray has been accepted for review by the Food and Drug Administration (FDA). If approved as submitted, the product will be indicated for acute relief of an
attack or acute prophylaxis of angina pectoris due to coronary artery disease.
The submission was made as a 505(b)(2) application, a form of NDA that
references and relies on data developed by NovaDel and historical data
published in the literature. The Prescription Drug User Act (PDUFA) goal date
is June 4, 2005.
On Sept. 7, NovaDel and Par Pharmaceutical Companies, Inc. (NYSE:PRX) announced
an agreement granting Par exclusive rights to market, sell and distribute
aerosol nitroglycerin lingual spray in the US and Canada. NovaDel is
responsible for obtaining regulatory approval for the product and for supplying
the product to Par. NovaDel will receive milestone payments and royalties on
sales of the product.
NovaDel Pharma Inc. is a specialty pharmaceutical company engaged in the
development of novel drug delivery systems for prescription and over-the-
counter drugs. The Company's proprietary lingual spray technology delivery
system offers the patient the potential for (i) fast onset of action; (ii)
improved drug safety by reducing the required drug dosage and reducing side
effects; (iii) improved patient convenience and compliance; and (iv) enhanced
dosage reliability. The Company plans to develop such products independently
and through collaborative arrangements with major pharmaceutical and biotech
companies. To find out more about NovaDel Pharma Inc. (AMEX:NVD), visit our
website at http://www.novadel.com/.
Except for historical information contained herein, this document contains
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements involve known and unknown risks
and uncertainties that may cause the Company's actual results or outcomes to be
materially different from those anticipated and discussed herein including, but
not limited to, the successful completion of its pilot pharmacokinetic
feasibility studies, the ability to develop products (independently and through
collaborative arrangements), the ability to commercialize and obtain FDA and
other regulatory approvals for products under development and the acceptance in
the marketplace for lingual spray products.. Further, the Company operates in
industries where securities may be volatile and may be influenced by regulatory
and other factors beyond the Company's control. Important factors that the
Company believes might cause such differences are discussed in the risk factors
detailed in the Company's most recent Annual Report and Registration
Statements, filed with the Securities and Exchange Commission. In assessing
forward-looking statements contained herein, if any, the reader is urged to
carefully read all cautionary statements contained in such filings.
Contacts:
Barry C. Cohen Thomas Redington
VP Business & New Product Development Redington, Inc. NovaDel Pharma Inc. 203-222-7399
908-782-3431 ext. 2160 212-926-1733
DATASOURCE: NovaDel Pharma Inc.
CONTACT: Barry C. Cohen, VP Business & New Product Development of NovaDel Pharma Inc., +1-908-782-3431 ext. 2160; or Thomas Redington of Redington, Inc., +1-203-222-7399, or +1-212-926-1733, , for NovaDel Pharma Inc.
Web site: http://www.novadel.com/
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