MAP Pharmaceuticals Announces FDA Acceptance for Filing of NDA Resubmission
--New PDUFA date April 15, 2013--
MOUNTAIN VIEW, Calif., Nov. 21, 2012
MOUNTAIN VIEW, Calif., Nov. 21, 2012 /PRNewswire/ -- MAP Pharmaceuticals, Inc.
(Nasdaq: MAPP) today announced that its New Drug Application (NDA)
resubmission for LEVADEX® orally inhaled migraine drug for the potential acute
treatment of migraine in adults has been accepted for filing by the U.S. Food
and Drug Administration (FDA). The FDA has classified the resubmission as a
complete, Class 2 response to the FDA's March 26, 2012 action letter and has
set a goal date of April 15, 2013 under the Prescription Drug User Fee Act.
"The acceptance of our LEVADEX resubmission is an important milestone for the
company," said Timothy S. Nelson, president and chief executive officer of MAP
Pharmaceuticals. "We will continue to work closely with the FDA through the
review process, with the goal of providing the underserved migraine patient
population with a potential new treatment option in 2013."
About MAP Pharmaceuticals
MAP Pharmaceuticals is a biopharmaceutical company focused on developing and
commercializing new therapies to address undermet patient needs in neurology.
The Company is developing LEVADEX®, an orally inhaled investigational drug for
the acute treatment of migraine. The New Drug Application for LEVADEX is
currently under review by the U.S. Food and Drug Administration. MAP
Pharmaceuticals has entered into a collaboration agreement with Allergan, Inc.
to co-promote LEVADEX to neurologists and pain specialists in the U.S. and
Canada. The Company also applies its proprietary drug particle and inhalation
technologies to generate new pipeline opportunities by enhancing the
therapeutic benefits of proven drugs, while minimizing risk by capitalizing on
their known safety, efficacy and commercialization history. Additional
information about MAP Pharmaceuticals can be found at
In addition to statements of historical facts or statements of current
conditions, this press release contains forward-looking statements, including
with respect to the FDA goal date for MAP Pharmaceuticals' LEVADEX product
candidate. Actual results may differ materially from current expectations
based on risks and uncertainties affecting the company's business, including,
without limitation, risks and uncertainties relating to the regulatory
approval process for the Company's LEVADEX product candidate. The reader is
cautioned not to unduly rely on the forward-looking statements contained in
this press release. MAP Pharmaceuticals expressly disclaims any intent or
obligation to update these forward-looking statements, except as required by
law. Additional information on potential factors that could affect MAP
Pharmaceuticals' results and other risks and uncertainties are detailed in its
most recent Quarterly Report on Form 10-Q, available at http://edgar.sec.gov.
MAP Pharmaceuticals Contact:
Lisa Borland (media), 650-386-3122
Chris Chai (investors), 650-386-3107
SOURCE MAP Pharmaceuticals, Inc.
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