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Cysview Approval History

FDA Approved: Yes (First approved May 28, 2010)
Brand name: Cysview
Generic name: hexaminolevulinate
Dosage form: for Intravesical Solution
Previous Name: Hexvix
Company: Photocure ASA
Treatment for: Diagnosis and Investigation

Cysview (hexaminolevulinate HCl) is an optical imaging agent indicated for use in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder.

Development History and FDA Approval Process for Cysview

DateArticle
Jun  2, 2010Approval Cysview (Hexaminolevulinate HCl) Approved by the FDA for Cystoscopic Detection of Papillary Bladder Cancer
Nov 23, 2009FDA has posted an Advisory Committee meeting with Photocure to discuss Hexvix NDA
Sep  1, 2009Photocure ASA (NO) - Hexvix has been granted priority review by the FDA
Jul  1, 2009Photocure submits application for marketing approval for Hexvix in USA to the FDA
Apr 20, 2006FDA Requests More Information Related to Hexvix NDA

Further information

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