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Rytary FDA Approval History

FDA Approved: Yes (First approved January 7, 2015)
Brand name: Rytary
Generic name: carbidopa and levodopa
Dosage form: Extended Release Capsules
Company: Impax Laboratories, Inc.
Treatment for: Parkinson's Disease

Rytary (carbidopa and levodopa) is an extended release aromatic amino acid decarboxylation inhibitor and aromatic amino acid combination indicated for the treatment of Parkinson’s disease.

Development timeline for Rytary

DateArticle
Oct 19, 2022BioVie’s Phase 2 Trial Assessing NE3107's Pro-motoric Activity in Parkinson's Disease is Fully Enrolled
Jan  8, 2015Approval Impax Pharmaceuticals Announce FDA Approval of Rytary (carbidopa and levodopa) for Parkinson's Disease
Apr 11, 2014Impax Pharmaceuticals Resubmits NDA for Rytary (Carbidopa and Levodopa) Extended-Release
Jan 25, 2013FDA Issues Complete Response Letter for Rytary (Carbidopa and Levodopa) Extended-Release Capsules (IPX066) New Drug Application
Oct 12, 2012Impax Pharmaceuticals Announces Extension of Rytary FDA Review Date to January 21, 2013
Feb 23, 2012FDA Accepts Impax Pharmaceuticals NDA Filing for IPX066 for the Treatment of Idiopathic Parkinson's Disease
Dec 21, 2011Impax Pharmaceuticals Submits New Drug Application for IPX066 in Parkinson's Disease

See also

Rytary (carbidopa and levodopa) Consumer information

Further information

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