Mylan's apomorphine on track for approval
Mylan Laboratories has reported that its subsidiary, Bertek Pharmaceuticals, has received an approvable letter from the US Food and Drug Administration for its New Drug Application for use of 10mg/mL apomorphine hydrochloride injection in the treatment of Parkinson's disease.
The NDA was accepted for filing in January 2003 and was granted fast-track designation. Mylan said in a statement that final approval was subject to the submission of additional information requested by the FDA.
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