FDA approval Zofran- Ondansetron clinical trails
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FDA approval for Zofran- Ondansetron

Ondansetron drug commonly known as Zofran is used for treatment of nausea and vomiting induced by chemotherapeutic treatment. Zofran came into existence in 1984 at Glaxo's laboratories and several clinical trials were undertaken before the company sent this pill for FDA approval in 1986. Zofran was patented in the year 1987 under U.S. patent protection program with U.S. Patent number 4695578.

It was not until the year 1991 that this fill manufactured by its manufacturer Glaxo's laboratories was awarded FDA (Food and drug administration) approval. Glaxo's laboratories did extensive research along with various new clinical trials, due to this reason the manufacturer was awarded patent extension though the term of patent extension of this drug ended on December 26, 2006.

The first FDA approved generic version of Zofran came into existence in December 2006 after series of clinical trials. The present manufacturers of this pill are: GlaxoSmithKline (GSK) manufacturing under the name of Zofran, Gedeon Richter Ltd. The sale of this drug is under the name of Emetron. Cipla Ltd makes this pill under the name of Emeset, Korea United Pharmaceuticals marketing Ondansetron as Emodar.

Another player, Baxter Healthcare has got approval for the production of another variant of Ondansetron viz the Ondansetron injection. The constituents of injection Ondansetron will be of USP, 8 mg/50 mL including 32 mg/50 mL iso-osmotic sodium chloride solution. As this drug is known to have side effects it is only available through the prescription of qualified physician only. With its powerful effects in shielding effects of chemotherapy, the future of this drug seems quite bright.
 

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