Briefing Information for the June 26, 2009 Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee

Morning Session

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)

Ista Pharmaceuticals

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.

Bepreve (bepotastine besilate ophthalmic solution) 1.5%

Indication:  Treatment of ocular itching associated with allergic conjunctivitis (pdf)

Afternoon Session

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)

River Plate Biotechnology, 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.

Sodium hyaluronate ophthalmic solution 0.18% River Plate Biotechnology, Inc

Indication: For the treatment of the signs and symptoms of dry eye disease (pdf)