ELITE PHARMACEUTICALS, INC. (OTCMKTS:ELTP) Files An 8-K Regulation FD DisclosureItem 7.01
On January 30, 2018, in a press release, Elite Pharmaceuticals, Inc., or Elite, reported positive topline results from a pilot study conducted for SequestOx™, Elite’s immediate release Oxycodone Hydrochloride product that incorporates its proprietary abuse-deterrent technology. Elite intends to review with the FDA the study results and discuss the pharmacokinetic study requirements for a re-submission of the NDA.
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. |
(d) Exhibits.
| Exhibit No. | Description |
| 99.1 | Press Release dated January 30, 2018 |
ELITE PHARMACEUTICALS INC /NV/ ExhibitEX-99.1 2 tv484457_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Elite Pharmaceuticals Reports Positive Topline Results from SequestOx™ Pilot Study NORTHVALE,…To view the full exhibit click here
About ELITE PHARMACEUTICALS, INC. (OTCMKTS:ELTP)
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company. The Company is principally engaged in the development and manufacture of oral, controlled-release products. The Company develops and manufactures generic products, products using controlled-release drug technology, products utilizing abuse deterrent technologies, and it develops and markets generic controlled-release and abuse deterrent pharmaceutical products. Its segments include Abbreviated New Drug Applications (ANDA’s) for generic products and New Drug Applications (NDA’s) for branded products. The Company owns approximately six different approved ANDA’s. The Company’s product, SequestOx, is an immediate-release Oxycodone Hydrochloride containing sequestered Naltrexone, which incorporates five milligram, 10 milligram, 15 milligram, 20 milligram and 30 milligram doses of oxycodone into capsules. SequestOx is used for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.
