SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
July 9, 2018 (July 2, 2018)
Date of Report (Date of earliest event reported)
(Exact name of registrant as specified in
| (State or other jurisdiction
165 Ludlow Avenue, Northvale, New Jersey
(Address of principal executive offices)
(Registrant’s telephone number, including
|(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:
|¨||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))
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 7.01||Regulation FD Disclosure.
On July 2, 2018, in a press release, Elite
Pharmaceuticals, Inc., or Elite, reported approval of the Company’s abbreviated new drug application (ANDA) from the U.S.
Food and Drug Administration (FDA) for generic Percocet® (Oxycodone Hydrochloride and Acetaminophen, USP CII) 5 mg/325 mg,
7.5 mg/325 mg and 10 mg/325 mg tablets.
A copy of the press release is furnished
as Exhibit 99.1 to this Current Report on Form 8-K. The information set forth in this Item 7.01 and contained in the press release
furnished as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of
1934, as amended, or the Exchange Act, and is not incorporated by reference into any of Elite’s filings under the Securities
Act of 1933, as amended, or the Securities Act, or the Exchange Act, whether made before or after the date hereof, except as shall
be expressly set forth by specific reference in any such filing.
|Item 9.01||Financial Statements and Exhibits.
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: July 9, 2018
||/s/ Nasrat Hakim|
||Nasrat Hakim, President and CEO|