Impax Laboratories Inc said the U.S. Food and Drug Administration had approved Rytary, its drug for treating Parkinson's disease.
Impax's shares rose 12 pct at $34.67 in premarket trading.
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
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