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Thursday
Valeant's Zelapar 'approvable' by FDA
pecialty drug company Valeant Pharmaceuticals International said Tuesday that it received an "approvable letter" from the Food and Drug Administration for Parkinson's disease treatment Zelapar.
An approvable letter informs the sponsor of a drug that their marketing application is in order but that other issues need to be resolved before final approval. Valeant said that it will meet with the FDA soon to clarify issues it had previously addressed with the agency. The company did not elaborate on the nature of the issues.MORE..businessweek.com
An approvable letter informs the sponsor of a drug that their marketing application is in order but that other issues need to be resolved before final approval. Valeant said that it will meet with the FDA soon to clarify issues it had previously addressed with the agency. The company did not elaborate on the nature of the issues.MORE..businessweek.com