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11 Jan 2015

Impax’s Parkinson’s Drug Gets FDA Approval

Rytary Approval History

  • FDA approved: Yes (First approved January 7th, 2015)
  • Brand name: Rytary
  • Generic name: carbidopa and levodopa
  • Company: Impax Laboratories, Inc.
  • Treatment for: Parkinson’s Disease

Impax Laboratories Inc said the U.S. Food and Drug Administration had approved Rytary, its drug for treating Parkinson’s disease.

The FDA had previously rejected the drug, citing issues with the company’s manufacturing plant in Hayward, California. The agency later raised concerns about Impax’s factory in Taiwan.

Rytary is a long-acting capsule formulation of carbidopa-levodopa, the standard of care for Parkinson’s disease.

The FDA approval of Rytary (pronounced rye-TAR-ee) is an important new development for the treatment of Parkinson’s disease and provides an extended-release carbidopa-levodopa product that treats Parkinson’s disease. Rytary is designed to address one of the most significant unmet needs for patients living with Parkinson’s disease, which is to reduce the amount of time during the day when their symptoms are not adequately controlled. – Fred Wilkinson, president and CEO, Impax Laboratories. 

“Rytary is designed to address one of the most significant unmet needs for patients living with Parkinson’s disease, which is to reduce the amount of time during the day when their symptoms are not adequately controlled,” he added.

Rytary contains immediate release and extended-release beads, with a specific amount of carbidopa and levodopa in a 1:4 ratio, and provides both initial and extended levodopa plasma concentrations after a single dose. Rytary may be swallowed whole or, for patients who have trouble swallowing, the capsule may be opened and the beads sprinkled on applesauce and consumed immediately.

Impax expects the four strengths of Rytary, 23.75mg/95mg, 36.25mg/145mg, 48.75mg/195mg, and 61.25mg/245mg (carbidopa/levodopa) to be available next month.

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