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Extravan FDA Approval Status

FDA Approved: No
Brand name: Extravan
Generic name: travoprost and timolol
Dosage form: Ophthalmic Solution
Company: Alcon Laboratories, Inc.
Treatment for: Glaucoma

Extravan (Travoprost 0.004% + Timolol 0.5% Fixed Combination (TTFC)) is a prostaglandin analogue and beta-blocker combination intended for use in the treatment of glaucoma.

In September 2004, Alcon, Inc. announced the receipt of an Approvable Letter from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for Extravan. While the combination is currently available in many countries, it remains commerically undeveloped in the United States.

Development timeline for Extravan

DateArticle
Sep 17, 2004Alcon Receives Approvable Letter for Extravan
Jan 28, 2004Alcon Files NDA for Combination Drug to Treat Glaucoma; Releases PreliminaryClinical Data at Major Ophthalmology Meeting

Further information

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