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FDA rejects ANDA paediatric bioequivalence call, and OKs Glenmark's Cutivate generic

This article was originally published in Scrip

Executive Summary

Glenmark Generics' US arm has received final approval from the US FDA for its ANDA for fluticasone propionate 0.05% lotion, a generic version of Nycomed's Cutivate lotion, a product used for inflammatory and pruritic manifestations of atopic dermatitis and worth about $48 million in US sales (IMS data).

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