FDA approves Novadel’s Zolpimist for short-term insomnia treatment
FLEMINGTON, N.J. The Food and Drug Administration has approved a drug by NovaDel Pharma for the short-term treatment of insomnia characterized by difficulties with sleep initiation, NovaDel announced Monday.
NovaDel said that Zolpimist (zolpidem tartrate) is its second product approved by the FDA that uses its proprietary NovaMist spray technology. The active ingredient in Zolpimist is the same as the one in Sanofi-Aventis’ Ambien.
“We believe that the FDA’s approval of Zolpimist provides patients with an important treatment option for insomnia, as Zolpimist provides rapid absorption from the oral mucosa,” NovaDel board chairman and interim CEO Steven Ratoff said.
Ambien had worldwide sales of $559.3 million for first six months of 2008, according to Sanofi-Aventis financial data.
AstraZeneca seeks approval for use of Nexium in infants
NEW YORK AstraZeneca has submitted a supplemental application to the Food and Drug Administration for the use of the drug Nexium as a short-term treatment of gastroesophageal reflux disease in infants.
GERD, which is closely related to acid-reflux disease, affects about 7 million children in the United States.
The FDA has already approved Nexium (esomeprazole magnesium) for use in children between 1 and 17 years of age, though AstraZeneca hopes to have it approved in infants less than a year old.
Amgen applies for FDA approval of denosumab osteoporosis, cancer treatment
THOUSAND OAKS, Calif. Amgen has submitted an approval application to the Food and Drug Administration for denosumab, a treatment for women with postmenopausal osteoporosis and patients undergoing hormone ablation for prostate and breast cancer, the biotech company announced Friday.
The approval application contains data from six phase 3 trials involving more than 11,000 patients, the company said. Amgen also plans to submit applications in Canada, Australia, the European Union and Switzerland.
“Today’s submission marks a significant step toward realizing our goal of making this important therapeutic available to patients at risk for fractures, for whom there is a significant need for new therapies,” Amgen EVP for research and development Roger Perlmutter said.