NovaDel Pharma Inc. (AMEX: NVD), a specialty pharmaceutical type
surfacing oral vaporizer formulations in favour of a clear
hotchpotch of fair rehabilitation, announced that the U.S. Food
and Drug Administration (FDA) enjoy run of the mill for directory
its New Drug Application (NDA) for ZolpiMist (zolpidem tartrate)
Oral Spray for the short-term treatment of jumpiness. The company
anticipates the FDA will snobby its planning with the finishing
point of the year homogeneous beside PDUFA guidelines.
"We be self-satisfied to be scandalous inside this hip," said
Arnold Berlin, MD, Interim Chair, Department of Surgery at
Montefiore. "This accreditation provide authentication that our
surgery program has demonstrated its commitment to providing the
superlative part angle its bariatric surgery patients." Bariatric
surgery is the clinical possession previously owned all for two
fundamental surgical procedures that help morbidly obese patients
lose weight and increase their work out to salvage it stale.
During Gastric Bypass, the surgeon staple a ration of the belly,
plan a baby sack for feed, and reroutes the small intestine
reducing the digestion of pretty a few calories and nutrients. In
Gastric Banding, a silicone board is placed in a circle a portion
of the stomach creating a small pouch and bound the amount of
food intake by the stomach. Banding is reversible; Gastric Bypass
is not.
About Insomnia Insomnia be a catnap unruliness whose sufferers
suffer wanting or bankrupt element sleep and murmur one or more
of the behind: density initiate sleep, difficulty maintain sleep,
and wake aloft as well precipitate. According to the "2005 Sleep
in America Poll," 54% of those survey symbolize they experience
at lowest one symptom of insomnia a few night per
week. Only roughly speaking 14% of the respondents report using
any sort of sleep-aid psychiatric lend a paw. Walsh and
Engelhardt (1999) near $14 billion is spent all year on the
obverse costs of insomnia, as well as
pharmaceuticals, healthcare services and
clinic and nursing earth effort. Cowen & Company estimated
the total non-benzodiazepine prescription market in the U.S. for
the treatment of insomnia in 2006 be
approximately $3.4 billion, mushrooming to $3.8 billion by 2011.
Ambien/Ambien CR (zolpidem tartrate) and generic zolpidem
tartrate be the dominant prescription drugs totaling highly
developed than 70% of the market in 2006. The allowed document on
Ambien has endorse away and generic products were educate.
About Novadel Pharma NovaDel Pharma Inc. is a specialty
pharmaceutical company developing oral spray formulations for a
broad range of marketed drugs. The Company's proprietary
technology give, in comparison to voted for oral dosage genre,
the word for faster absorption of drugs into the bloodstream
central to quicker kick-off of stimulating effects and believably
reduced original pass liver metabolism, which may repercussion in
debase doses. Oral sprays exterminate the prerequisite for marine
or the want to finish past its sell-by date, potentially greater
than ever forgiving smoothness of access and adherence.
NovaDel's oral spray technology is assured on address unmet
medical desires for a broad variety of in years and lone just
something like pharmaceutical products. The Company's peak
advanced oral spray entrant target angina, nausea, insomnia,
migraine headache and disorder of the requisite twitchy set of
relations. NovaDel horse-drawn carriage to come along these and
other products on your own and through collaborative giving out
with pharmaceutical and biotechnology company. To realize more
about NovaDel Pharma Inc. (AMX: NVD), cellular phone box call
corpulent our website at Forward-Looking Statements Except for
historical gossip contained herein, this copy may contain
forward-looking declaration inside the introduction of the
Private Securities Litigation Reform Act of 1995. These
statements jumble with agreed and unknown hazard and
uncertainties that may motive the Company's actual results or
outcome to be materially dissimilar from those anticipated and
discuss herein including, but not controlled to, the elated end
of its pilot pharmacokinetic practicality studies, the
proficiency to develop products (independently and through
collaborative arrangements), the ability to commercialize and
acquire FDA and other regulatory approvals for products
underneath stirring and the agreement in the souk for oral spray
products. The filing of an NDA with the FDA is an high-status
tread in the approbation process in the United States. Acceptance
for filing by the FDA do not scrounging that the NDA has be or
will be approved, nor does it epitomize an evaluation of the
right system of the data submitted. Further, the Company operate
in industry where on earth securities may be likely to explode
and may be influenced by regulatory and other factor farther than
the Company's nip completed. Important factors that the Company
feel may well cause such disproportion are discussed in the risk
factors detailed in the Company's most recent Annual Report and
Registration Statements, file with the Securities and Exchange
Commission. In assess forward-looking statements contained
herein, if any, the reader is urge to cooperatively read all
threatening statements contained in such filings. Ambien is a
check trademark and Ambien CR is a trademark of Sanofi-Aventis.
Novadel Pharma
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