ELITE PHARMACEUTICALS, INC. (OTCMKTS:ELTP) Files An 8-K Other Events
Item 8.01
| Other Events. |
Elite Pharmaceuticals, Inc. (Elite or the Company) met with the
U.S. Food and Drug Administration (the FDA) on December 21, 2016
for an end-of-review meeting to discuss steps that Elite can take
to obtain approval of SequestOxTM. Based on the FDA
response, the Company believes there is a clear path forward to
address the issues cited in the July 14th Complete
Response Letter. The FDA will provide minutes of the meeting by
the end of January and the Company will issue a further update at
that time.
For more information on the SequestOx end-of-review meeting,
please see the December 22, 2016 press release, a copy of which
is furnished herewith as Exhibit 99.1.
Caution Concerning Forward Looking Statements
This Current Report contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Including those related to the effects, if any, on future
results, performance or other expectations that may have some
correlation to the subject matter of this Current Report, readers
are cautioned that such forward-looking statements involve risks
and uncertainties including, without limitation, Elites ability
to obtain FDA approval of the transfers of the ANDAs or the
timing of such approval process, delays, uncertainties, inability
to obtain necessary ingredients and other factors not under the
control of Elite, which may cause actual results, performance or
achievements of Elite to be materially different from the
results, performance or other expectations that may be implied by
these forward-looking statements. These forward-looking
statements may include statements regarding the expected timing
of approval, if at all, of SequestOx by the FDA, the steps Elite
may take as a result of the CRL, the results of an End of Review
Meeting and what actions the FDA may require of Elite in order to
obtain approval of the NDA. These forward-looking statements are
not guarantees of future action or performance. These risks and
other factors, including, without limitation, Elites ability to
obtain sufficient funding under the LPC Agreement or from other
sources, the timing or results of pending and future clinical
trials, regulatory reviews and approvals by the Food and Drug
Administration and other regulatory authorities, intellectual
property protections and defenses, and the Elites ability to
operate as a going concern, are discussed in Elite’s filings
with the Securities and Exchange Commission, including its
reports on forms 10-K, 10-Q and 8-K. Elite is under no obligation
to update or alter its forward-looking statements, whether as a
result of new information, future events or otherwise.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. | Description |
| 99.1 | Press Release dated December 22, 2016 |
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. ELITE PHARMACEUTICALS, INC. (OTCMKTS:ELTP) Recent Trading Information
ELITE PHARMACEUTICALS, INC. (OTCMKTS:ELTP) closed its last trading session down -0.001 at 0.165 with shares trading hands.