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Acorda Therapeutics refiles drug application for Parkinson's treatment

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Acorda Therapeutics refiles drug application for Parkinson's treatment

Acorda Therapeutics Inc. resubmitted its new drug application with the U.S. Food and Drug Administration for Inbrija, a Parkinson's disease treatment.

The drug is indicated to treat patients experiencing so-called off-periods — when the effects of a medication start to wear off in between doses — or the re-emergence of Parkinson's symptoms.

Acorda said the resubmission contains information on the two concerns raised by the FDA, along with additional requested data, detailed in the agency's refusal to file letter.

The company said it expects to be notified by the FDA within 74 days if the submission is complete and permitted to undergo a full review.