ELTP Elite Pharmaceuticals
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
May 5, 2021
Date of Report (Date of earliest event reported)
ELITE PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction|
|(Commission File Number)||(IRS Employer|
165 Ludlow Avenue, Northvale, New Jersey 07647
(Address of principal executive offices)
(Registrant’s telephone number, including area code)
|(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. ☐
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||Trading Symbol(s)||Name of each exchange on which registered|
|Common Stock, par value $0.001 per share||ELTP||OTCQB|
|Item 8.01.||Other Events.|
On May 4, 2021, Elite Pharmaceuticals, Inc. ("Elite" or the “Company") issued a press release to announce the launch of Loxapine Succinate capsules (“Loxapine Capsules” or the “Product”), 5 mg, 10 mg, 25 mg and 50 mg with its distribution and marketing partner Prasco, LLC (“Prasco”).
A copy of the press release is being finished with this Current Report on Form 8-K as Exhibit 99.1.
On February 14, 2020, Elite Pharmaceuticals Inc. (“Elite”) entered into a license, supply, and distribution agreement, and amended on July 30, 2020, with Prasco to be the exclusive United States distributor for Elite’s Abbreviated New Drug Application (ANDA) for the Loxapine Capsules. The product will be distributed under the Burel label.
Under the Agreement, Prasco will provide sales, marketing, and distribution for the Product, and Elite will manufacture the Product and receive manufacturing fees and a profit split. The term of the License Agreement is three years, with one year renewal terms.
|Item 9.01||Financial Statements and Exhibits.|
|99.1||Press Release dated May 4, 2021|
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: May 5, 2021||ELITE PHARMACEUTICALS, INC.|
|By:||/s/ Nasrat Hakim|
Nasrat Hakim, President and CEO