FDA Approves Waiver of NDA Filing Fee for Elite Pharmaceuticals
Elite to Submit New Drug Application for ELI-200
NORTHVALE, N.J.,
Jan. 13, 2016 (GLOBE NEWSWIRE) -- The United State Food and Drug
Administration (“FDA”) granted Elite Pharmaceuticals, Inc. ("Elite" or
the “Company") (ELTP)
a waiver of the application fee required for the filing of a New Drug
Application (NDA). Under section 736(d)(1)(E) of the Federal Food, Drug
and Cosmetic Act the FDA may grant a waiver of the $2,335,200 NDA
application fee for the first human drug application that a small
business submits for review.
Elite
will immediately submit a 505(b)(2) New Drug Application for its lead
opioid abuse-deterrent candidate ELI-200, immediate-release Oxycodone
Hydrochloride 5mg, 10mg, 15 mg, 20 mg and 30mg capsules with sequestered
Naltrexone Hydrochloride, for the treatment of moderate to severe pain
with the United States Food and Drug Administration. FDA notification
regarding acceptance of the submission for review is expected to take 6
to 12 weeks.
"Having the
FDA waive the application fee is a huge benefit to Elite. We will file
the ELI-200 submission immediately. I look forward to hearing from the
FDA concerning a notification of the acceptance for review in the coming
weeks,” said Nasrat Hakim, President and Chief Executive Officer of
Elite.
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