FDA Approves Impax Parkinson’s Drug Despite Persistent Quality Problems

The FDA approved Impax Labs’ Parkinson’s disease drug Rytary after the drugmaker agreed to not use a troubled manufacturing facility for production.

The agency initially rejected Rytary (IPX066) in 2013 due to quality problems at Impax’s Hayward, Calif., manufacturing facility, which was supposed to assist in production and distribution of the drug. The rejection later caused GlaxoSmithKline to abandon a marketing agreement for Rytary.

The FDA required a satisfactory reinspection of Hayward in order for the drug to be approved. However, the agency reinspected the facility in June and July of last year and issued a Form 483 with seven observations.

Impax withdrew Hayward as an alternative site for production, according to the company’s latest financial report.

The product will now be manufactured solely at Impax’s Taiwan plant, spokesman Mark Donohue said.

However, that site has had its own quality problems. The facility received a Form 483 for a slew of quality violations such as failing to reject poor quality batches and failing to properly validate equipment.

Donohue said Impax responded to the 483’s observations.

Rytary is an extended-release formulation of carbidopa-levodopa, and is intended to treat Parkinson’s disease and postencephalitic Parkinsonism and Parkinsonism, a neurological disorder, which can occur after carbon monoxide and/or manganese intoxication.

Impax submitted Rytary for European approval in November. — Robert King