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): September 12, 2006
DUSA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
NEW JERSEY 0-19777 22-3103129
(State or other jurisdiction of (Commission File Number) (IRS Employer
incorporation) Identification Number)
25 UPTON DRIVE
WILMINGTON, MASSACHUSETTS 01887
(Address of principal executive offices, including ZIP code)
(978) 657-7500
(Registrant's telephone number, including area code)
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 Securities 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.
DUSA Pharmaceuticals, Inc. ("DUSA") has been informed that Actavis Totowa,
LLC received a warning letter from the U.S. Food and Drug Administration ("FDA")
regarding certain regulatory observations. Actavis Totowa, formerly known as
Amide Pharmaceuticals, Inc., is the contract manufacturer of Nicomide(R). The
primary observations noted in the warning letter were not related to
Nicomide(R). However, with respect to Nicomide(R) and certain other products
manufactured by Actavis Totowa, the FDA has requested that the manufacturer
provide a copy of the labeling and information providing the basis for an
exemption from the drug approval requirements. The FDA regulates such products
under the compliance policy guide entitled, "Marketed New Drugs without Approved
NDAs or ANDAs." DUSA is working with the manufacturer in order to respond
appropriately to the FDA.
Nicomide(R) is one of the key products DUSA acquired from Sirius
Laboratories, Inc. in connection with our merger completed in March, 2006.
Nicomide(R) is an oral prescription vitamin supplement.
In addition, as DUSA has previously stated, certain of the Sirius products
acquired in connection with the merger must meet certain minimum manufacturing
and labeling standards established by the FDA and applicable to products
marketed without approved marketing applications. FDA regulates such products
under its marketed unapproved drugs compliance policy mentioned above. Under
this policy, FDA recognizes that certain unapproved products, based on the
introduction date of their active ingredients and the lack of safety concerns,
have been marketed for many years and, at this time, will not be the subject of
any enforcement action. We believe that so long as we comply with applicable
manufacturing and labeling standards we will be consistent with FDA's current
enforcement policy. There can be no assurance that the FDA will continue this
policy or not take a contrary position with any individual products. If the FDA
were to do so, we may be required to seek FDA approval for these products,
market these products as over-the-counter products or as dietary supplements
under applicable legislation, or withdraw such products from the market.
Except for historical information this report contains certain
forward-looking statements that involve known and unknown risk and
uncertainties, which may cause actual results to differ materially from any
future results, performance or achievements expressed or implied by the
statements made. These forward-looking statements relate to our beliefs
regarding the applicability of FDA's guidance to our products and potential
ramifications thereof. Furthermore, the factors that may cause differing results
include the regulatory process and environment, actions or inactions of
third-parties, sources of funding, maintenance of its patent portfolio and other
risks identified in DUSA's SEC filings from time to time.
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.
DUSA PHARMACEUTICALS, INC.
By: /s/ D. Geoffrey Shulman
------------------------------------
D. Geoffrey Shulman, MD, FRCPC
Chairman of the Board and
Chief Executive Officer
Dated: September 12, 2006