ZensanaTreatment for Nausea/Vomiting -- Chemotherapy Induced
FDA Accepts for Review NDA Filing for Zensana (Ondansetron HCl) Oral Spray
SOUTH SAN FRANCISCO, Calif., August 30, 2006 -- Hana Biosciences, a biopharmaceutical company focused on advancing cancer care, today announced the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for Zensana (ondansetron HCl) Oral Spray. Hana submitted an NDA for Zensana to seek approval for the prevention of chemotherapy, radiation, and post-operative associated nausea and vomiting. The acceptance of the filing means the FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive review.
"With this NDA filing, we are excited to be one step closer to bringing relief to patients suffering from nausea and vomiting as a result of their cancer treatments," stated Mark Ahn, President and CEO. "We plan to continue working closely with the FDA during the review. Subject to FDA approval, we look forward to a potential commercial launch in the United States in the first half of 2007."
Hana completed bioequivalence and bioavailability clinical trials of Zensana in early 2006 and submitted its NDA under Section 505(b)(2) of the Food, Drug and Cosmetic Act on June 30, 2006. This form of registration relies on data in previously approved NDAs and published literature. The expected Prescription Drug User Fee Act (PDUFA) action date for this NDA is April 30, 2007.
About Zensana (ondansetron HCl) Oral Spray
Zensana (ondansetron HCl) Oral Spray is the first 5-HT3 antagonist to deliver ondansetron, a standard antiemetic therapy, in a convenient, micromist oral spray to patients suffering from chemotherapy, radiation, and post-operative associated nausea and vomiting. Based on clinical trial data presented June 3, 2006 at the American Society of Clinical Oncology Conference, Hana believes Zensana is statistically bioequivalent to ondansetron tablets with faster initial delivery. Ondansetron, a selective blocking agent of the hormone serotonin, is an FDA-approved active ingredient that is widely used in tablet form to prevent chemotherapy, radiation, and post-operative associated nausea and vomiting. Many patients requiring antiemetic therapy experience dysphagia, a discomfort or difficulty swallowing tablets, due to mouth and throat sores, inflammation, or dry mouth. Hana believes that the convenience of drug delivery via an oral spray may offer an attractive alternative to tablets and other forms of ondansetron. Hana holds the exclusive rights to market the novel oral spray formulation in the U.S. and Canada pursuant to a license from NovaDel Pharma, Inc. (AMEX:NVD).
Source: Hana Biosciences, Inc.
Posted: August 2006
- Par Pharmaceutical Licenses North American Rights to Zensana from Hana Biosciences - August 1, 2007
- FDA Approves First Generic Ondansetron Injection - November 22, 2006
- Hana Biosciences Submits Zensana NDA to the FDA - June 30, 2006
- Hana Biosciences Reaffirms Expected Timing of First NDA Filing - May 9, 2006