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First generic of Zofran.(Updates)(SICOR Pharmaceuticals Inc.; Kali Laboratories Inc.)(Brief article)
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FDA Consumer
- Article date:
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March 1, 2007
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Copyright informationCOPYRIGHT 2007 U.S. Government Printing Office. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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The FDA has approved the first generic versions of Zofran (ondansetron) injection, injection premixed, tablets, orally disintegrating tablets, and oral solution.
Ondansetron is indicated to prevent nausea and vomiting associated with surgery, radiotherapy, and cancer chemotherapy. Ondansetron Injection and Injection Premixed were approved in November 2006. Ondansetron Tablets, Orally Disintegrating Tablets, and Oral Solution were approved in December 2006.
The approvals are an important step in the agency's effort to increase the availability of lower-cost generic medications. In 2005, Zofran was the 20th ...
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NEW PRODUCT NEWSWIRE
Drug Topics;
January 22, 2007 ;
Anonymous;
787 words
......versions of ondansetron tablets, orally disintegrating tablets, and oral solution...440) 232-3320, ondansetron injection (2 mg/mL packaged...908) 203-4900, ondansetron hydrochloride...732) 537-0400, ondansetron orally disintegrating tablets (4, 8, 16, and...800) ...
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New formulations
Formulary;
October 1, 2004 ;
Anonymous;
504 words
...Parcopa Carbidopa-levodopa orally disintegrating tablets SCHWARZ PHARMA Rapid-dissolving...with carbidopa-levodopa orally disintegrating tablets and must be discontinued at least...combination. Carbidopa-levodopa orally disintegrating tablets are contraindicated in patients...
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 "Globes (Tel Aviv, Israel)")
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FDA approves Teva chemotherapy side effects treatment.
Globes (Tel Aviv, Israel);
February 27, 2006 ;
286 words
......drug application) for Ondansetron Injection USP, 2 mg/mL, packaged...single-dose vials, and Ondansetron Injection USP, 2 mg/mL, packaged...final approval, Teva's Ondansetron Injection products will be the...
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OLANZAPINE.(Zyprexa Zydis orally disintegrating tablets introduced)(Brief...
Chemical Market Reporter;
September 25, 2000 ;
41 words
...Eli Lilly & Co. has launched Zyprexa Zydis (olanzapine orally disintegrating tablets), a new formulation that dissolves in the mouth on contact with saliva. The formulation is the first of its kind for an antipsychotic. It is available in 5mg and 10mg tablets.
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Baxter Receives Tentative FDA Approvals For Ondansetron Injection In Vials...
PR Newswire;
June 15, 2006 ;
586 words
......and Drug Administration (FDA) for Ondansetron Injection USP, including the first tentative...application (ANDA) approvals for Ondansetron Injection USP 2 mg/mL packaged in 40 mg/20...application (NDA) approval for Ondansetron Injection USP 32 mg/50 mL iso-osmotic sodium...
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Bedford Laboratories(TM) to Begin Shipping Ondansetron Injection USP.
PR Newswire;
December 26, 2006 ;
372 words
......announced that it will begin marketing Ondansetron Injection USP as of December 26, 2006. This...to Zofran(R) by GlaxoSmithKline. Ondansetron Injection USP is indicated for prevention...pleased to announce the addition of Ondansetron Injection USP to our portfolio, said David...
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Alamo Pharmaceuticals Launches New FazaClo(TM)(clozapine, USP) Orally...
PR Newswire;
July 21, 2004 ;
556 words
......FazaClo(TM) (clozapine, USP) Orally Disintegrating Tablets to the nation's psychiatrists today...new freedom that FazaClo orally disintegrating tablets present. No longer will clozapine...who receive FazaClo(TM) Orally Disintegrating Tablets. PRESCRIBING INFORMATION Please...
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WOCKHARDT LAUNCHES ONDANSETRON INJECTION IN U.S.
The Hindustan Times;
December 27, 2006 ;
261 words
......Wockhardt's USA Inc. Wockhardt's US subsidiary, launched Ondansetron injection in the United States on December 26, 2006, the first...12 months ending September 30, 2006, was $628 million. Ondansetron injection is manufactured at the US FDA certified sterile formulation...
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FDA Grants Monthly WBC Monitoring for FazaClo(R) (clozapine, USP).
PR Newswire;
May 18, 2005 ;
772 words
...Patient Registry for FazaClo Orally Disintegrating Tablets Already Configured for Convenient...their illness. And FazaClo Orally Disintegrating Tablets dissolve in 15-30 seconds on the...Patients Like the FazaClo Orally Disintegrating Tablets(1) In a study where patients were...
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Mylan Announces Tentative FDA Approval for Ondansetron Orally...
PR Newswire;
February 26, 2007 ;
177 words
......for its Abbreviated New Drug Application (ANDA) for Ondansetron Orally Disintegrating Tablets USP, 4mg and 8mg strengths. Ondansetron Orally Disintegrating Tablets are the generic version of GlaxoSmithKline's Zofran ODT(R) Tablets...
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Barr Receives Approval for and Launches Mirtazapine Orally Disintegrating...
PR Newswire;
December 18, 2003 ;
787 words
......Administration (FDA) for Mirtazapine Orally Disintegrating Tablets, 15mg and 30mg, the generic equivalent...Application (ANDA) for mirtazapine orally disintegrating tablets in December 2001. The ANDA contained...Orange Book for mirtazapine orally disintegrating tablets were invalid ...
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Barr Receives Tentative Approval for a Generic Version of Zofran ODT(R)...
PR Newswire;
August 27, 2004 ;
766 words
......Zofran ODT(R) (ondansetron) Orally Disintegrating Tablets, 4mg and 8mg. The Company anticipates...exclusivity. Barr's Ondansetron Orally Disintegrating Tablets are indicated for the prevention...Application (ANDA) for Ondansetron Orally Disintegrating Tablets, 4mg and 8mg in March ...
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Mylan Announces Tentative FDA Approval for Ondansetron Orally...
U.S. Newswire;
February 26, 2007 ;
181 words
......for its Abbreviated New Drug Application (ANDA) for Ondansetron Orally Disintegrating Tablets USP, 4mg and 8mg strengths. Ondansetron Orally Disintegrating Tablets are the generic version of GlaxoSmithKline's Zofran ODT(R) Tablets...
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FDA approves first generic 5-HT-3 antagonist
Drug Topics;
January 8, 2007 ;
LoBuono, Charlotte;
443 words
...The Food & Drug Administration has approved ondansetron injection, USP (TEVASICOR Pharmaceuticals). The proproduct...prevention of postoperative nausea and vomiting (PONV). Ondansetron injection is currently available in the United States through...received permission to market ondansetron orally ...
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