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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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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): August 12, 2005
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ABLE LABORATORIES, INC.
(Exact name of registrant as specified in its charter)
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Delaware 001-11352 04-3029787
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(State or other (Commission File Number) (IRS Employer
jurisdiction of Identification Number)
incorporation)
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1 Able Drive, Cranbury, NJ 08512
(Address of Principal Executive Offices) (Zip Code)
(609) 495-2800
(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:
|_| 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 Rue 13e-4(c) under the Exchange
Act (17 CFR 240.13e-4(c))
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Item 8.01 Other Events.
On August 15, 2005, Able Laboratories, Inc. (the "Company") announced a
decision by its Board of Directors taken as a result of discussions it has been
conducting with the Food and Drug Administration (the "FDA") regarding its
ongoing review of internal laboratory practices and related issues. The Company
proposed to the FDA that it be permitted to re-validate the product development
data included in its previously approved Abbreviated New Drug Applications (each
an "ANDA"), under new management and with data being verified by an independent
outside consultant. The Company proposed that it would relaunch products
underlying these ANDAs upon completion of the revalidation work without the need
for full FDA review and approval of all the data supporting each ANDA. The FDA
declined the proposal, advising that the most expeditious relaunch of the
products would require withdrawal, resubmission (with new data), and full FDA
review. The Company announced its belief that even under an expedited approach,
FDA review of the ANDAs could take up to 18 months in each case, and that it
will not be able to return any of its products to market, and therefore produce
any revenue for a significant period of time. The Company further announced that
it has determined that the best course of action to preserve value for it
creditors and others would be to immediately reduce overhead and expenses as
much as possible and to initiate the process of selling its business and assets
to one or more third-party purchasers, rather than attempting to obtain
financing to permit it to resume manufacturing and marketing on its own. The
Company further announced that there is no guarantee, and in fact that it is
unlikely, that shareholders of its common stock will receive proceeds from such
sale or sales, and that it is not likely that the common stock has any value.
The Company also announced that Paul D. Cottone, the Company's Chief
Restructuring Officer, had resigned, but that he will continue to assist the
Company on a consulting basis, and that Richard M. Shepperd, the Company's
Director of Restructuring, would continue with the Company.
The full text of the press release is attached to this report as Exhibit
99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits
(a) Financial Statements of Businesses Acquired:
Not Applicable.
(b) Pro Forma Financial Information:
Not Applicable.
(c) Exhibits:
99.1 Press Release, dated August 15, 2005
SIGNATURE
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.
ABLE LABORATORIES, INC.
By: /s/ Richard M. Shepperd
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Name: Richard M. Shepperd
Dated: August 16, 2005 Title: Director of Restructuring
INDEX TO EXHIBITS
Exhibit Paper (P) or
Number Exhibit Electronic (E)
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99.1 Press Release, dated August 15, 2005 E