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FDA approval granted for generic paclitaxel.(Brief Article)
2002 JUL 11 - (NewsRx.com & NewsRx.net) -- Abbott Laboratories (ABT) and NaPro BioTherapeutics, Inc., (NPRO) announced that they have received approval from the U.S. Food and Drug Administration (FDA) to market Paclitaxel Injection, the most widely used anticancer compound in the United States.
Paclitaxel is equivalent to Bristol-Myers Squibb's Taxol (paclitaxel) Injection, an antitumor product indicated for the treatment of metastatic carcinoma of the ovary after the failure of first-line or subsequent chemotherapy. Paclitaxel is also indicated for the treatment of breast cancer after the failure of combination chemotherapy for metastatic disease.
"We are pleased to be able to offer a high quality alternative for paclitaxel patients," said Christopher B. Begley, senior vice president, hospital products, Abbott Laboratories. "This approval further demonstrates Abbott's company-wide commitment to the oncology community and bringing specialty generic products to market."
Leonard P. Shaykin, chairman and chief executive officer, NaPro BioTherapeutics, commented, "This approval is a milestone for NaPro and adds the U.S. market to approximately 25 other countries in which NaPro's formulation of paclitaxel is already distributed. We are proud of this accomplishment, and look forward to advancing the other therapeutics in our pipeline, including both natural products and other anticancer compounds, as well as our unique gene alteration technology."
Abbott and NaPro have been collaborating since July 1999 to provide paclitaxel to ...
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- News wire article from: Chemical Business Newsbase December 10, 2001 700+ words
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- NaPro Announces Webcast of FDA Approval Conference Call.
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...HealthWire)--May 8, 2002 NaPro BioTherapeutics, Inc...today's FDA approval of Paclitaxel Injection. The conference call will...website. Leonard P. Shaykin, NaPro's Chairman and Chief Executive...com. Please connect to NaPro's web site several minutes...
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- FDA Confirms First Filed Paclitaxel Injection Application
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- TAXOL (paclitaxel) Injection Approved by FDA for Expanded Administration...
- Press release article from: PR Newswire July 10, 2000 700+ words
...today that the U.S. Food and Drug Administration has approved a novel, shorter administration regimen for TAXOL (paclitaxel) injection for the treatment of advanced ovarian cancer. The FDA granted approval for this new dosing regimen based on results...
- Nippon Kayaku: Paclitaxel Injection NK.
- News wire article from: Chemical Business Newsbase July 24, 2006 700+ words
(From Chemical Business NewsBase - Pharma Japan) On 7 Jul 2006, Nippon Kayaku launched Paclitaxel Injection NK (paclitaxel) into the Japanese market. The product is priced at Yen 10,357 for 30ml and Yen 30,640 for 100ml (NHI prices...
- Bristol-Myers Squibb.(paclitaxel injection)
- Magazine article from: Medical Marketing & Media November 1, 1999 700+ words
The Oncologic Drugs Advisory Committee unanimously recommended that the FDA approve Bristol-Myers Squibb's Taxol (paclitaxel) injection for sequential administration to doxorubicin-containing therapy for the adjuvant treatment of node-positive breast cancer.
- Faulding Announces Addition of Paclitaxel Injection to Its U.S. Product Line.
- Press release article from: PR Newswire September 9, 2003 700+ words
Faulding Pharmaceutical Co. announced that it is in the process of adding Paclitaxel Injection to its line of oncology products and hopes to begin marketing the product in the United States in October. The product is equivalent...
Source: HighBeam Research, FDA approval granted for generic paclitaxel.(Brief Article)