Impax wins an FDA nod after years of setbacks

Impax Laboratories ($IPXL) finally won FDA approval for the Parkinson's disease treatment Rytary, capping a saga of delays, regulatory warnings and cutbacks. The pill, an extended-release combination of carbidopa and levodopa, is designed to provide better control of Parkinson's symptoms than shorter-acting alternatives, the company said, and its approval marks Impax's first success with an internally developed drug. Rytary endured an FDA rejection back in 2013, leading ex-partner GlaxoSmithKline ($GSK) to back out of its deal. The ensuing months of back and forth with the agency over manufacturing issues cut into Impax's bottom line, and in October the company cut 42 R&D employees, about 25% of its research staff, and trimmed its focus to assets in Phase II or above. More

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