Avanir (AMEX:AVN)
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From Jan 2020 to Jan 2025
AVANIR Pharmaceuticals (AMEX:AVN) announced that it has
been advised by the U.S. Food and Drug Administration (FDA) today that
it should not expect a determination on the acceptability, or
otherwise, of its New Drug Application (NDA) for Neurodex for the
treatment of pseudobulbar affect (PBA) until October 10, 2005. The FDA
determined that the receipt date of the filing is to be August 10,
2005, due to supplemental data provided by the Company on that date at
the request of the FDA. In the interim, the company anticipates
continuing communication with the FDA routinely associated with a NDA.
AVANIR Pharmaceuticals is focused on developing and
commercializing novel therapeutic products for the treatment of
chronic diseases. AVANIR's product candidates address therapeutic
markets that include central nervous system and cardiovascular
disorders, inflammation, and infectious disease. AVANIR has initiated
a Phase 3 clinical trial of Neurodex for the treatment of diabetic
neuropathic pain. AVANIR has active collaborations with two
international pharmaceutical companies, Novartis, for the treatment of
inflammatory disease, and AstraZeneca, for the treatment of
cardiovascular disease. The Company's first commercialized product,
Abreva(R), is marketed in North America by GlaxoSmithKline Consumer
Healthcare and is the leading over-the-counter product for the
treatment of cold sores. Further information about AVANIR can be found
at www.avanir.com.
Statements in this press release that are not historical facts,
including statements that are preceded by, followed by, or that
include such words as "estimate", "anticipate", "believe", "plan", or
"expect", or similar statements are forward-looking statements that
are subject to certain risks and uncertainties that could cause actual
results to differ materially from the future results expressed or
implied by such statements. There can be no assurance that AVANIR's
New Drug Application for Neurodex(TM) will be accepted for filing by
the FDA within the anticipated time period or at all; that Neurodex
will receive regulatory approval; or that even if such regulatory
approval is received, AVANIR will be able to market Neurodex
successfully. Final review decisions made by the FDA and other
regulatory agencies concerning clinical trial results are often
unpredictable and outside the influence and/or control of the company.
Risks and uncertainties also include the risks set forth in AVANIR's
most recent Annual Report on Form 10-K and subsequent Quarterly
Reports on Form 10-Q and from time-to-time in other publicly available
information regarding the Company. Copies of this information are
available from AVANIR upon request. AVANIR disclaims any intent or
obligation to update these forward-looking statements.