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Arxxant FDA Approval Status

FDA Approved: No
Brand name: Arxxant
Generic name: ruboxistaurin mesylate
Company: Eli Lilly and Company
Treatment for: Diabetic Retinopathy

Arxxant (ruboxistaurin mesylate) is an investigational specific protein kinase C beta (PKC beta) inhibitor for the treatment of diabetic retinopathy.

In August 2006, Lilly announced the receipt of an Approvable Letter from the from the U.S. Food and Drug Administration (FDA), advising the company that it will require efficacy data from an additional Phase 3 study before it will consider approving the molecule.

Development timeline for Arxxant

Sep 29, 2006Lilly Announces FDA Requirement of Additional Clinical Trial Before Ruboxistaurin Could Be Approved for Treatment of Diabetic Retinopathy
Aug 18, 2006Eli Lilly and Company Announces Approvable Letter Issued by FDA for Arxxant
Aug  2, 2005Lilly Will Submit Arxxant to FDA in 2005

Further information

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