Valeant Zelapar "approvable" again
This article was originally published in Pharmaceutical Approvals Monthly
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)...
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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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