Valeant Responds To Zelapar Approvable Letter, Plans For Mid-2005 Launch
This article was originally published in Pharmaceutical Approvals Monthly
Valeant responds to Zelapar “approvable” letter for Parkinson’s disease; “complete response” includes two safety studies, as requested in FDA’s 2003 approvable letter for the MAO-B inhibitor. Selegiline safety concerns include drug interactions, hypertension due to “cheese effect”
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Valeant's fast-dissolving oral selegiline formulation Zelapar is "approvable" for the second time, the firm says Oct. 4. The company plans to meet with FDA "promptly as they have requested" to discuss the letter requesting "additional clarification on specific issues previously addressed by Valeant." Valeant responded to a February 2003 approvable letter in January (1Pharmaceutical Approvals Monthly January 2005, p. 27) for use of the MAO-B inhibitor as an adjunct to levodopa/carbidopa in Parkinson's disease. The response included two safety studies. The MAO-B inhibitor class carries extensive drug interaction concerns. Oral selegiline capsules are marketed as Somerset's Eldepryl and generics. Somerset has a transdermal selegiline patch, Emsam, under review for depression (2Pharmaceutical Approvals Monthly January 2005, p. 27)...
Somerset’s resubmitted NDA for the selegiline patch Emsam seeks an indication for relapse prevention as well as treatment of depression.
Teva will likely emphasize the once-daily dosing and metabolic profile of its MAO-B inhibitor rasagiline to distinguish the Parkinson’s disease therapy from selegiline.