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®,
=======================================================================
What is What is 510(k) Clearances ?
What is 510(k) Clearances, Premarket Notification for medical devices – PMN or 510(k)

Antibiotic Definition and classification

Antibiotic resitance and Drug resistance mechanism

Antioxidants food suppliments

Vitamin D Details on FDA cautions on accurate dosage of Vitamin D

What is an antibody? what is monoclonal and polyclonal antibodies?

Enzyme linked immunosorbent assay ELISA

Raido Immuno assay
http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definations.

http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html

Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in pharmaceutical industry

Pharmaceutical Validation

Types of validations in pharmaceutical manufacturing

Requirements of documents for validation of sterilisation process

How to investigate OOS out of specification results

Determination of Phenol coeeficient of a disinfectant

Sterility testing

Cleen Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Controling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation

New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA

How to make Investigational New Drug (IND) Application to US FDA

Drug applications submission to us fda Over the counter Drugs OTC drugs

BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Eletronic record in pharmaceutical manufacturing industry

Good manufacturing practice in pharmaceutical industry

Pharmaceutical industry pharmaceutical companies and FDA latest updates

Here is an intresting article on world wide pharmaceutical industry
Article on Pharmaceutical Industry pharmaceutical industry

Here are some interesting articles on Quality assurance systems for pharmaceutical company
1.Quality assurance in pharma industry
2.Quality by designe concept for pharmaceutical industry
3.Quality by designe concept in pharmaceutical industry an  explanation