FDA issues tentative approval for Noven’s Stavzor
MIAMI Noven Pharmaceuticals Thursday announced that the Food and Drug Administration has issued a tentative approval letter for Stavzor delayed release capsules.
The drug is indicated for treatment of manic episodes associated with bipolar disorder, monotherapy and adjunctive therapy in multiple seizure types (including epilepsy), and prophylaxis of migraine headaches.
Stavzor (valproic acid delayed release capsules) was developed using Banner Pharmacaps’ patent-pending EnteriCare enteric soft gelatin capsule delivery system. Noven acquired a license to market and sell Stavzor in the United States as part of its acquisition of JDS Pharmaceuticals in August 2007. Banner submitted the new drug application for Stavzor in 125mg, 250mg and 500mg strengths. The FDA stated in the letter that it has completed its review of the amended Stavzor NDA and that it is tentatively approved.
The NDA for Stavzor, Noven stated, does reference Abbott Laboratories’ Depakote product; however, if approved for marketing, Stavzor will be a branded product, and not AB-rated to or generically substitutable for Depakote, nor will Depakote or any Depakote generics be substitutable for Stavzor.
“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 Strauss, Noven’s President, chief executive officer & Chairman. “Stavzor launch and production planning is underway in support of an expected 2008 launch through the Noven/JDS sales and marketing organization.”
Stake in drug-testing contractor purchased in $3 billion-plus deal
NEW YORK In a deal worth a reported $3 billion-plus, One Equity Partners’ stake in drug trial manager Quintiles Translational is being sold to its chief executive and other buyout firms, including Bain Capital and TPG Capital, according to The New York Times.
Dennis Gillings, founder of Quintiles and its chief executive officer and chairman, has teamed up with Bain and TPG to take control of the stake from One Equity, the private equity arm of JPMorgan Chase, which also sponsored the company’s $1.7 billion buyout in 2003.
Gillings had previously offered to buy the company in 2002 for $1.3 billion, but that number was rejected as being too low.
Quintiles, based in Research Triangle Park, N.C., has more than 19,000 employees. At the time of its founding in 1982, Gillings was a professor of biostatistics at the University of North Carolina. The company went public in 1994.
Jazz, Solvay receive approvable letter from FDA regarding extended-release Luvox
PALO ALTO, Calif. The Food and Drug Administration issued an approvable letter for Jazz Pharmaceuticals’ Once-a-Day Luvox CR (fluvoxamine maleate), which the company is trying to market as an extended-release capsule indicated for the treatment of social anxiety disorder and obsessive compulsive disorder.
Jazz has teamed up with Solvay Pharmaceuticals to market the drug. The FDA earlier this month approved the regular formulation of Luvox for the treatment of OCD.
The companies are seeking clarification from the FDA and look forward to working with the FDA to resolve any issues as quickly as possible. They stressed that the approvable letter did not raise any questions related to the safety or efficacy of Luvox CR.