Current Report Filing (8-k)
December 19 2017 - 9:04AM
Edgar (US Regulatory)
UNITED
STATES
SECURITIES AND
EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO
SECTION 13 OR 15(D)
OF THE SECURITIES
EXCHANGE ACT OF 1934
December 19, 2017 (December 15, 2017)
Date of Report
(Date of earliest event reported)
ELITE
PHARMACEUTICALS, INC.
(Exact name
of registrant as specified in its charter)
Nevada
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001-15697
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22-3542636
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(State or other jurisdiction
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(Commission
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(IRS Employer
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of incorporation)
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File Number)
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Identification No.)
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165 Ludlow
Avenue, Northvale, New Jersey 07647
(Address of
principal executive offices)
(201) 750-2646
(Registrant’s
telephone number, including area code)
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(Former
name or former address, if changed since last report.)
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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:
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¨
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Written communications pursuant to Rule 425 under the
Securities Act (17 CFR 230.425)
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¨
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Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12)
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¨
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Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b))
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¨
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Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the
registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of
this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
¨
If an emerging growth company, indicate
by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act.
¨
Item 8.01 Other Events
On December 15, 2017, Elite Pharmaceuticals, Inc., ("Elite"
or the “Company") received a close-out letter from the Food and Drug Administration, Office of Compliance with respect
to the August 25, 2016 FDA Warning Letter regarding Post Marketing Adverse Drug Experience (PADE) reporting. The FDA has concluded
its evaluation and the corrective actions undertaken by the Company are now complete. There are no longer any potential restrictions
from the Warning Letter. Elite remains responsible to continue to maintain compliance with FDA regulations.
On December 4, 2017, the FDA completed a pre-approval inspection
for a filed generic product. The inspection was classified as “No Action Indicated” (NAI) because the FDA did not issue
any observations.
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.
Dated: December 19,
2017
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ELITE PHARMACEUTICALS, INC.
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By:
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/s/ Nasrat Hakim
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Nasrat Hakim, President and CEO
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