ZensanaTreatment for Nausea/Vomiting -- Chemotherapy Induced
Hana Biosciences Reaffirms Expected Timing of First NDA Filing
SOUTH SAN FRANCISCO, Calif., May 9, 2006 - Hana Biosciences, a biopharmaceutical company focused on advancing cancer care, provided an update today on its most advanced drug candidate, Zensana (ondansetron HCl) Oral Spray. Hana completed pivotal trials for Zensana in early 2006, which it believes met endpoints sufficient to allow for a New Drug Application (NDA) filing with the Food and Drug Administration under section 505(b)(2) of the Food, Drug and Cosmetic Act, a form of registration that relies on data in previously approved NDAs and published literature. The Company held a voluntary meeting with the FDA yesterday to discuss its planned NDA application. The Company continues to believe it remains on track for a submission in the second quarter of 2006. Subject to approval by the FDA, the company plans to commercially launch Zensana in the United States in 2007.
About Zensana (ondansetron HCl) Oral Spray
The Company believes that Zensana (ondansetron HCl) Oral Spray is the only multidose oral spray 5-HT3 antagonist product candidate currently in development. Zensana delivers full doses of ondansetron to patients receiving emetogenic chemotherapy. Ondansetron is FDA approved to prevent chemotherapy and radiation-induced, and post-operative nausea and vomiting. Patients experiencing nausea and vomiting have difficulty swallowing and holding down pills. Drug delivery via a spray to the oral mucosa is designed to avoid degradation in the gastrointestinal tract and metabolism by liver enzymes -- the so-called first-pass effect. Hana licensed the exclusive rights to Zensana in the U.S. and Canada from NovaDel Pharma, Inc.
Source: Hana Biosciences, Inc.
Posted: May 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 Submits Zensana NDA to the FDA - June 30, 2006