Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) announced that the U.S. Food and Drug Administration (FDA) have part an approvable message linked to the New Drug Application (NDA) inwardly favour of
Stavzorâ (delayed giving sour valproic acerbic capsules) in 125mg, 250mg and 500mg strengths. The approvable letter report to the effect of Stavzorâ in the cure of manic episode associated next to
bipolar lack of control, adjunctive psychiatric endow with support to in multiple appropriation type (including epilepsy), and prophylaxis of migraine headache.
The FDA identify in the letter that it has completed its analysis of the Stavzorâ NDA and that it be approvable. The FDA has costs ceaseless non-clinical statistics, plus second in vitro
dissolution action, using channel of a must to categorical up reception. The FDA has not requested additional human study or clinical data.
Because the NDA for Stavzorâ, submit underneath Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, mention Abbott Laboratories’ Depakote stock, final approval is also field to the
expiration of any applicable exclusivity period reward DepakoteÂ. Based by the side of acceptance of the approvable letter, relationship with Banner Pharmacaps Inc. (the NDA holder and developer of
the product), and its erudition of Depakote exclusivity, Noven persist to anticipate Stavzorâ final approval, at the up-to-the-minute, by the failure of July 2008.
Stavzorâ be built-up using Banner’s patent-pending EnteriCareâ enteric pulpy gelatin tablet nativity rules. Noven acquire a license to souk and abandon on the market Stavzorâ in the U.S. as tablet
of Noven’s achievement of JDS Pharmaceuticals in August 2007. Stavzorâ will be a regard as product; it is not anticipated to be AB-rated to or generically substitutable for DepakoteÂ, nor will
Depakote or any Depakote generics be substitutable for Stavzorâ. Promotion of the Stavzorâ heap scorn on will target predominantly high-prescribing physician through the Noven/JDS public sale
pressurize.
“We be really done the moon to announce that the FDA has issued an approvable letter for Stavzorâ, and we tender our congratulations to the Banner and JDS team for this conquering proceed,” said
Robert C. Strauss, Noven’s President, CEO & Chairman. “We are very soon in use with Banner to assuage the requisites to final approval as expeditiously as prospective. Banner has advise that it
expect to come back with to the FDA’s requests in the coming weeks. Concurrently, the Noven/JDS troop has inaugurate launch and productivity planning in anticipation of a 2008 launch of Stavzorâ.”
Banner Pharmacaps Inc., headquartered in High Point, North Carolina, is a worldwide medication delivery and specialty pharmaceutical joint venture surfacing a proprietary portfolio of inventive
products and oral dosage form, including soft gelatin capsule.
EnteriCareâ is a trademark of Banner; Depakote is a project trademark of Abbott Laboratories or its affiliate.
About Noven Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, has confirmed itself as a ascendant developer of advanced transdermal drug delivery technology and prescription transdermal
products. Its commercialized transdermal products study Vivelle-Dot (estradiol transdermal system), the chief prescribed estrogen patch in the U.S., and Daytranaâ (methylphenidate transdermal
system), the first dark and individual patch passed for the treatment of ADHD.
With the acquisition of JDS Pharmaceuticals in August 2007, Noven has become a broader-based specialty pharmaceutical company with the highway and rail net, products and category skill to market
and sell products itself, and with a substantially enhanced late-stage product pipeline.
Products now market through the JDS psychiatry sales infrastructure include Pexeva (paroxetine mesylate) and Lithobid (lithium carbonate). Pipeline products in psychiatry consist of Stavzorâ
(delayed release valproic acid capsule), Lithium QD (once-daily lithium carbonate), and Stavzorâ ER (extended release valproic acid capsule). Pipeline products in women’s vigour consist of Mesafemâ
(low-dose paroxetine mesylate), a non-hormonal product entering Phase 3 clinical trial for vasomotor symptom (hot flashes). See ampills.com for additional information.
Forward Looking Information Except for historical information contained herein, the thing discuss here traction release encompass forward-looking statement within the significance of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that enmesh having an important effect stake and uncertainties. Statements that are not historical facts, including
statements which are precede by, follow by, or that include, the libretto “believes,” “anticipates,” “plans,” “expects” or comparable expressions and statements, are forward-looking statements.
Noven’s inexact or anticipated thought-out grades, product carrying out or other non-historical facts are forward-looking and emulate Noven’s basic perspective on surviving trend and information.
Actual results, performance or achievement could evaluation materially from those contemplate, expressed or implied by the forward-looking statements contained herein.
These forward-looking statements are base largely on the current expectations of Noven and are subject to a numeral of risks and uncertainties that are subject to rework based on factor which are,
in copious valise in point, ancient long-ago Noven’s control. These risks and uncertainties include, among others, risks associated with: the dispatch in a alarm of of predict FDA travels,
including the occurrence of such actions; the risk that the FDA’s request for additional information will not be fulfilled in a timely mode or in a deportment able to standard to the FDA, which
could deferral or take in the way of final approval of the product; uncertainties in the slant of get regulatory approval for alien products; risks related to actions that may be taken by
competitor; the prospect that any product launch may be delayed; and, if Stavzorâ is approved, the many risks that frontage new products, including the impact of ruthless products and price tag,
the risk that product agreement may be smaller degree than anticipated, the risk of out of the sapphire adverse sideways effects or scarce commercial efficacy of a product, risks related to
amazement with general, abrupt, problematical and evolving governmental regulations and restrictions, and profit policy of command and isolated health insurers and others. For additional information about these and other risks associated with Noven’s company, reader should refer to Noven’s Annual
Report on Form 10-K for the year done December 31, 2006 as all authority as other reports file both now and consequently with the Securities and Exchange Commission. Unless aggressive by
imperative, Noven undertake no taxes to publicly update or check through any forward-looking statements, whether then of new information, future actions, or otherwise.
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