ZensanaTreatment for Nausea/Vomiting -- Chemotherapy Induced
Hana Biosciences Submits Zensana NDA to the FDA
Hana Biosciences Submits Zensana (ondansetron HCl) Oral Spray New Drug Application to the U.S. Food and Drug Administration
SOUTH SAN FRANCISCO, Calif., June 30, 2006 - Hana Biosciences, a biopharmaceutical company focused on advancing cancer care, today announced that the company has submitted a New Drug Application (NDA) for Zensana (ondansetron HCl) Oral Spray to the U.S. Food and Drug Administration (FDA) seeking marketing approval for the prevention of nausea and vomiting associated with chemotherapy, radiotherapy, and post-operative induced nausea and vomiting.
"Hana is pleased to be submitting its first NDA for Zensana which has the potential to provide a new treatment option for patients suffering from nausea and vomiting associated with chemo and radiation therapy," stated Mark Ahn, President and CEO. "This NDA marks a significant step for our company, is an example of our core competencies, and paves the way for further growth."
The NDA was filed under Section 505(b)(2) of the Food, Drug and Cosmetic Act. If approved, Hana targets commercial launch of Zensana in the United States in the first half of 2007.
About Zensana (ondansetron HCl) Oral Spray
Zensana (ondansetron HCl) is the first oral spray 5-HT3 antagonist to deliver ondansetron, a standard antiemetic therapy, in a convenient, micromist oral spray to patients suffering from chemotherapy, radiation and post-operatively induced nausea and vomiting. Based on clinical trial data presented June 3, 2006 at the American Society of Clinical Oncology (ASCO) 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-operatively induced nausea and vomiting. Many patients requiring antiemetic therapy experience discomfort or difficulty swallowing. Hana believes that the convenience of drug delivery via a spray may offer an attractive alternative to tablets and other forms of ondansetron. Hana completed bioequivalence and bioavailability clinical trials of Zensana in early 2006 and filed its NDA under Section 505(b)(2) of the Food, Drug and Cosmetic Act. A 505(b)(2) form of registration relies on data in previously approved NDAs and published literature. 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.
Source: Hana Biosciences, Inc.
Posted: June 2006
- Par Pharmaceutical Licenses North American Rights to Zensana from Hana Biosciences - August 1, 2007
- FDA Approves First Generic Ondansetron Injection - November 22, 2006
- FDA Accepts for Review NDA Filing for Zensana (Ondansetron HCl) Oral Spray - August 30, 2006
- Hana Biosciences Reaffirms Expected Timing of First NDA Filing - May 9, 2006