Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards

Strativa’s NDA for Ondansetron Orally Dissolving Film Strip Accepted by FDA

By Pharmaceutical Processing | June 10, 2009

Strativa Pharmaceuticals, the proprietary products division of a wholly ownedsubsidiary of Par Pharmaceutical Companies, Inc., has announcedthat the FDA has accepted its New DrugApplication (NDA) for ondansetron orally dissolving film strip (ODFS).Strativa is seeking approval of ondansetron ODFS for the prevention of nauseaand vomiting associated with highly- and moderately-emetogenic chemotherapy,radiotherapy and surgery. The ODFS, a new oral formulation of ondansetron designed to rapidlydissolve on the tongue, was developed using MonoSol Rx’ proprietaryPharmaFilm(TM) thin film technology. In clinical studies, this formulationdemonstrated bioequivalence to ondansetron orally disintegrating tablets(ODT), both with and without water. Pursuant to Prescription Drug User Fee Act(PDUFA) guidelines, Strativa expects the FDA will complete its review orotherwise respond to the NDA by the first quarter of 2010. “We are very pleased with the acceptance of our NDA submission and lookforward to cooperating with the FDA on its review,” said John A. MacPhee,President, Strativa Pharmaceuticals. “We believe the quick dissolving filmstrip formulation of ondansetron offers a convenient and easy-to-administeroption for managing nausea and vomiting associated with chemotherapy,radiotherapy and surgery.” Nausea and vomiting is a common side effect associated with chemotherapy,radiation and surgery. Left untreated, nausea and vomiting can have seriousconsequences such as exhaustion, dehydration and undernourishment, which caninterfere with treatment and healing. In June 2008, Strativa and MonoSol Rx entered into an exclusive licensingagreement under which Strativa acquired the U.S. commercialization rights toondansetron orally dissolving film strip.

Related Articles Read More >

FDA logo
FDA prevented 317 drug shortages in 2021
Pfizer-BioNTech vaccine vial
Pfizer, BioNTech moving forward on seeking COVID-19 vaccine EUA for youngest children
FDA logo
FDA curtails use of Janssen COVID-19 vaccine over blood clotting concerns
FDA logo
FDA sends warning letters to CBD and delta-8 THC product vendors

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Pharmaceutical Processing World
  • Subscribe to Our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards