Novartis’ Diovan approved to treat children age 6 and up
EAST HANOVER, N.J. Novartis announced at the beginning of the week that the Food and Drug Administration approved its drug Diovan (valstartan) to treat high blood pressure in children and adolescents aged 6 to 16, according to published reports.
Diovan is an angiotensin receptor blocker. Angiotensin II causes the muscles surrounding the blood vessels to contract, which narrows the blood vessels.
There have been estimates that nearly five percent of children and adolescents may suffer from high blood pressure. Experts suggest that the increase in incidence of high blood pressure among children and adolescents is linked to the growing pediatric obesity epidemic. The National Health and Nutrition Surveys has found the percentage of overweight children increased from 13.8 percent to 16 percent between 1999 and 2004, while the share of overweight adolescents rose from 14 percent to 18.2 percent during the same period.
No relevant differences were identified between the adverse experience profile for pediatric patients aged six to 16 and that previously reported for adult patients. Total annual market sales for valsartan tablets were $1.3 billion as of July 2007, according to IMS Health
Mylan’s nebivolol receives approvable letter from FDA, efficacy not at issue
NEW YORK Mylan’s new anti-hypertension drug has received a nearly green light from the Food and Drug Administration.
While an approvable letter from the FDA did not raise any questions related to safety or efficacy of nebivol, a novel beta blocker, Mylan and its licensing partner, Forest Laboratories, did report that final marketing approval would depend on the duo’s ability to resolve deficiencies in its manufacturing facility in Belgium, issues which the letter addressed.
At this time, the companies and the FDA have agreed upon product labeling text and the proposed brand name is currently Bystolic.
The companies anticipate an expeditious resolution to this issue, and Forest continues to plan for a Jan 2008 launch meeting for Bystolic.
Caraco receives tentative FDA approval for generic Lexapro
WASHINGTON The FDA has granted tentative approval for Caraco’s abbreviated new drug application for escitalopram oxalate tablets (escitalopram), 5 mg, 10 mg and 20 mg.
Escitalopram is indicated for the treatment of major depressive disorder and is the generic bioequivalent of Forest Laboratories’ Lexapro.
Caraco and Forest Laboratories have been involved in a patent litigation over the generic Lexapro since July. Lexapro tablets had U.S. sales of approximately $2.5 billion for the 12-month period ending Sept. 30, Caraco said.
“We are extremely pleased to receive this tentative approval,” said Caraco’s chief executive officer, Daniel Movens. “The ANDA was filed with a Paragraph IV certification that we do not infringe Forest’s Lexapro patents or that they are invalid. As previously disclosed, we are currently involved in litigation with Forest Laboratories that will determine whether we may launch our generic product prior to the expiration of these patents. Though the outcome of this litigation is uncertain, we remain confident in our position and continue to expect a favorable conclusion.”