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Friday, July 9, 2010

First prescriptional drug in oral soluble film approved by US US FDA.

FDA Approves First Prisciption medicines,Oral Soluble Film dosage form for ondansetron.

First of its kind in prescription medicine, oral soluble film for Prevention of chemotherapy-induced, radiotherapy-induced,and postoperative nausea and vomiting.

Strativa Pharmaceuticals company is one of subsidiary of Par Pharmaceutical Companies, they are successful in getting an approval from US FDA for their first of its kind oral soluble film for the treatment of  postoperative nausea and vomiting induced due to chemotherapy and radiation therapy .

Brand Name of this approved product is Zuplenz®

Zuplenz®, is the first and only one of its kind formulation of ondansetron in the form of oral soluble film approved by the US FDA as a prescription drug.

US FDA approved this formulation based on number of safety data and a clinical study data which compared the bioequivalence of orally dissolving tablet and the pharmacokinetic outcome of these studies was able to prove that a single dose of Oral Soluble Film, taken with food or in fasting conditions, was equivalent to the other approved oral dissolving tablet dosage form of the drug.

Zuplenz made use of the technology of PharmFilm® oral soluble film technology from MonoSol Rx for developing the film that rapidly dissolves on tongue even in without water , where patients who are in heavy vomiting and even cant take water, this kind of formulation will be helpful to treat such patients.

Oral Soluble Film Zuplenz will be made available in ondansetron 4 mg and ondansetron 8 mg dosage strengths.

Indication and Important Safety Information
ondansetron is indicated in prevention of postoperative nausea and vomiting related chemotherapy and radiotherapy



Ondansetron :
It is a serotonin and 5-HT3 receptor antagonist generally used for treatment nausea and vomiting related to chemotherapy, . Its acts both peripheral and central nerves system.

Vagus nerve activity is reduced by Ondansetron reduces which intern calms down activity in the vomiting center in the medulla oblongata, along with blocking of serotonin receptors present in chemoreceptor trigger zone.


Contra indications :

Ondansetron should not be used along with apomorphine which may result in profound hypotension and loss of consciousness.
Information about Par Pharmaceutical Companies, Inc.

Par Pharmaceutical Companies, Inc. is based in U.S it’s a specialty pharmaceutical company. its wholly-owns two subsidiary's companies Par Pharmaceutical and Strativa Pharmaceuticals.

For information about pharmaceutical companies world wide refer this --- Pharmaceutical companies

Information about MonoSol Rx
Pharmaceutical company who has developed systems and technology for drug delivery in lingual, sub-lingual in the form of buccal dissolving films their technology is known as PharmFilm®
This technology is successful in getting a prescription medicine approval from US FDA for Zuplenz®,
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