StavzorTreatment for Bipolar Disorder, Seizures, Epilepsy, Migraine Prophylaxis
Update: Stavzor Now FDA Approved - July 29, 2008
Noven Announces FDA Tentative Approval of Stavzor Valproic Acid Delayed Release Capsules
MIAMI--(BUSINESS WIRE)--Dec 26, 2007 - Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) today announced that the U.S. Food and Drug Administration (FDA) has issued a tentative approval letter related to the New Drug Application (NDA) for Stavzor (valproic acid delayed release capsules) in 125mg, 250mg and 500mg strengths. The tentative approval relates to the use of Stavzor in the treatment of manic episodes associated with bipolar disorder, monotherapy and adjunctive therapy in multiple seizure types (including epilepsy), and prophylaxis of migraine headaches.
The FDA states in the letter that it has completed its review of the amended Stavzor NDA and that it is tentatively approved. "Tentative approval" generally means that the FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but because of existing patents and/or exclusivity rights, it cannot yet be marketed in the United States.
The NDA for Stavzor, which was submitted by Banner Pharmacaps Inc. (the NDA holder and developer of the product) under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, references Abbott Laboratories' Depakote(R) product. Based on receipt of the tentative approval letter and Noven's understanding of Depakote(R) exclusivity, Noven continues to expect FDA final approval of Stavzor by the end of July 2008.
Stavzor was developed using Banner's patent-pending EnteriCare(TM) enteric soft gelatin capsule delivery system. Noven acquired a license to market and sell Stavzor in the U.S. as part of Noven's acquisition of JDS Pharmaceuticals in August 2007. If approved for marketing, Stavzor will be a branded product; it will not be AB-rated to or generically substitutable for Depakote(R), nor will Depakote(R) or any Depakote(R) generics be substitutable for Stavzor. Promotion of the Stavzor brand will occur through the Noven/JDS sales force.
"We are very pleased that Banner's response to the FDA's October 2007 approvable letter for Stavzor was deemed a complete response by the FDA, and that the FDA has granted tentative approval of this important new product for the treatment of three indications," said Robert C. Strauss, Noven's President, CEO & Chairman. "Stavzor launch and production planning is underway in support of an expected 2008 launch through the Noven/JDS sales and marketing organization."
FDA's letter does not raise any specific concerns about the safety or efficacy of Stavzor. Noven expects that the product label will contain similar warnings to those described in the Depakote(R) product label, including those relating to life threatening adverse reactions concerning hepatotoxicity, teratogenicity, and pancreatitis.
Banner Pharmacaps Inc., headquartered in High Point, North Carolina, is a global drug delivery and specialty pharmaceutical company developing a proprietary portfolio of unique products and oral dosage forms, including soft gelatin capsules.
EnteriCare is a trademark of Banner; Depakote(R) is a registered trademark of Abbott Laboratories or its affiliates.
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, has long been established as a leading developer of advanced transdermal drug delivery technologies and prescription transdermal products. Its commercialized transdermal products include Vivelle-Dot(R) (estradiol transdermal system), the most prescribed estrogen patch in the U.S., and Daytrana (methylphenidate transdermal system), the first and only patch approved for the treatment of ADHD. With the acquisition of JDS Pharmaceuticals in August 2007, Noven has become a broader-based specialty pharmaceutical company with a substantially enhanced late-stage product pipeline and the infrastructure, products and category expertise to market and sell its own products.
Products currently marketed through the Noven/JDS sales infrastructure consist of Pexeva(R) (paroxetine mesylate) and Lithobid(R) (lithium carbonate). Developmental products in psychiatry consist of Stavzor (delayed release valproic acid softgel), Lithium QD (once-daily lithium carbonate), and Stavzor ER (extended release valproic acid softgel). The development pipeline in women's health consists of Mesafem(TM) (low-dose paroxetine mesylate), a non-hormonal product entering Phase 3 clinical trials for vasomotor symptoms (hot flashes).
See www.noven.com for additional information.
Forward Looking Information
Except for historical information contained herein, the matters discussed in this press release contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve substantial risks and uncertainties. Statements that are not historical facts, including statements which are preceded by, followed by, or that include, the words "believes," "anticipates," "plans," "expects" or similar expressions and statements, are forward-looking statements. Noven's estimated or anticipated future results, product performance or other non-historical facts are forward-looking and reflect Noven's current perspective on existing trends and information. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained herein. These forward-looking statements are based largely on the current expectations of Noven and are subject to a number of risks and uncertainties that are subject to change based on factors which are, in many instances, beyond Noven's control. These risks and uncertainties include, among others, risks associated with: the difficulty of predicting FDA actions, including the timing of such actions; uncertainties in the process of obtaining regulatory approval for new products; risks related to actions that may be taken by competitors; the possibility that any product launch may be delayed; and, if Stavzor is approved, the many risks that face new products, including the impact of competitive products and pricing, the risk that product acceptance may be less than anticipated, the risk of unexpected adverse side effects or inadequate therapeutic efficacy of a product, risks related to compliance with extensive, costly, complex and evolving governmental regulations and restrictions, and reimbursement policies of government and private health insurers and others. For additional information regarding these and other risks associated with Noven's business, readers should refer to Noven's Annual Report on Form 10-K for the year ended December 31, 2006 as well as other reports filed from time to time with the Securities and Exchange Commission. Unless required by law, Noven undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Noven Pharmaceuticals, Inc., Miami
Joseph C. Jones, Vice President â?? Corporate Affairs,
Posted: December 2007
- Noven Announces Final FDA Approval of Stavzor for the Treatment of Bipolar Disorder, Seizures and Migraine Headaches - July 30, 2008
- FDA Issues Approvable Letter for Stavzor Delayed Release Valproic Acid Capsules - October 24, 2007