Briefing Information for the December 8, 2009 Joint Meeting of the Cardiovascular and Renal Drugs and Drug Safety and Risk Management Advisory Committees

FDA

 

Disclaimer

 

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. § 552).

FDA Briefing Material (pdf)

 

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Bayer HealthCare Pharmaceuticals, Inc.

 

Disclaimer

 

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

 

EOVIST Injection (gadoxetate disodium) Briefing Material (pdf)

MAGNEVIST (brand of gadopentetate dimeglumine) Injection and Pharmacy Bulk Package (pdf)

 

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Bracco Diagnostics, Inc.

 

Disclaimer

 

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

 

MultiHance Multipack (gadobenate dimeglumine) injection, 529mg/mL Briefing Material (pdf)

ProHance Multipack (gadoteridol injection) 279.3mg/mL Briefing Material (pdf)

 

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GE Healthcare, Inc.

 

Disclaimer

 

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

 

Omniscan Briefing Material (pdf)

 

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Lantheus Medical Imaging, Inc.

 

Disclaimer

 

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

 

Ablavar Injection (gadofosveset trisodium) Briefing Material (pdf)

 

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Mallinckrodt Inc., a Covidien Company

 

Disclaimer

 

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

 

OPTIMARK (gadoversetamide injection) Briefing Material (pdf)

Errata (pdf)