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APP Pharmaceuticals (APPX) Announces FDA Approval for Polymyxin B Sulfate for Injection
APP Pharmaceuticals, Inc. (NASDAQ: APPX) received approval from the FDA of its Abbreviated New Drug Application for Polymyxin B Sulfate for Injection, USP, 500,000 units/vial, the equivalent of Bedford Laboratories Polymyxin B Sulfate. APP expects to commence marketing the product in the first quarter of 2008. APP’s polymyxin B is AP-rated, preservative and latex-free, and bar-coded at the individual unit-of-use. According to 2006 IMS data, sales of Polymyxin B Sulfate for Injection exceeded $13 million.
FDA (more headlines)
APP Pharmaceuticals (APPX) Announces FDA Approval for Polymyxin B Sulfate for Injection
APP Pharmaceuticals, Inc. (NASDAQ: APPX) received approval from the FDA of its Abbreviated New Drug Application for Polymyxin B Sulfate for Injection, USP, 500,000 units/vial, the equivalent of Bedford Laboratories Polymyxin B Sulfate. APP expects to commence marketing the product in the first quarter of 2008. APP’s polymyxin B is AP-rated, preservative... (continued)
Stereotaxis (STXS) Announces FDA Approval of Its Partnered Magnetic Irrigated Catheter
Stereotaxis (NASDAQ: STXS) announced today that the Company has been advised that the U.S. Food and Drug Administration (FDA) has approved its partnered magnetic irrigated catheter for use in mapping and ablation in the United States.

"The long-awaited FDA approval of our partnered irrigated catheter is a very significant milestone for Stereotaxis,"... (continued)
Genzyme (GENZ) In License Agreement with Moffitt Cancer Center
Genzyme Corp. (NASDAQ: GENZ) entered into a license agreement with Moffitt Cancer Center to obtain exclusive worldwide diagnostic testing rights to the discovery... (continued)
ZymoGenetics (ZGEN) Announces Special Protocol Assessment for Atacicept
ZymoGenetics, Inc. (NASDAQ: ZGEN) said its partner Merck Serono has received agreement from the FDA regarding a Special Protocol Assessment for a Phase 2/3... (continued)
Progenics (PGNX) Initiates Phase 2 Clinical Trials for PRO 140, a HIV Antibody Therapy
Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) announced the initiation of the phase 2 clinical program for PRO 140, an investigational drug for the treatment... (continued)
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