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Glenmark fluticasone propionate 0.05% lotion gets FDA approval

Glenmark Generics Inc, the US subsidiary of the Glenmark Generics Ltd, has received the US Food and drug administration's (FDA) approval for fluticasone propionate 0.05% lotion abbreviated new drug application (ANDA).

Glenmark’s fluticasone propionate 0.05% lotion is the generic version of Nycomed US Cutivate lotion.

Cutivate (fluticasone propionate, 0.05%) lotion is a topical prescription medication for the relief of skin pain, redness and itching due to eczema in adults and in children one year of age and older.

Earlier, Nycomed has filed a lawsuit against Glenmark in December 2008, related to Glenmark’s ANDA for fluticasone propionate lotion.

If Glenmark successfully challenges Nycomed’s patent, it will be entitled to a 180-day exclusivity period.