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Tentative Approval Letter Issued for Valproic Acid Tablets
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 product. Based on receipt of the tentative approval letter and Noven’s understanding of Depakote 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 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, nor will Depakote® or any Depakote 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® product label, including those relating to life threatening adverse reactions concerning hepatotoxicity, teratogenicity, and pancreatitis.
Source: Noven Pharmaceuticals