USFDA gave tentative approval to the NDA for Stavzor

Noven Pharma. today announced that the USFDA has issued a tentative approval letter related to the New Drug Application (NDA) for Stavzor(TM) (valproic acid delayed release capsules) in 125mg, 250mg and 500mg strengths. The tentative approval relates to the use of Stavzor(TM) 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(TM) 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(TM), 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(TM) by the end of July 2008. Stavzor(TM) was developed using Banner's patent-pending EnteriCare(TM) enteric soft gelatin capsule delivery system. Noven acquired a license to market and sell Stavzor(TM) in the U.S. as part of Noven's acquisition of JDS Pharmaceuticals in August 2007. If approved for marketing, Stavzor(TM) 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(TM). Promotion of the Stavzor(TM) 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(TM) 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(TM) 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(TM). 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.