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Alembic’s JV Aleor Dermaceuticals bags US FDA approval for Mupirocin Cream

Mupirocin Cream is indicated for the treatment of traumatic skin lesion cream

Alembic Pharmaceuticals’ joint venture Aleor Dermaceuticals (Aleor) has received final approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Mupirocin Cream USP, 2 per cent. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bactroban Cream, 2 per cent, of SmithKline Beecham(Cork), Ireland (SmithKline).

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Mupirocin Cream USP, 2 per cent is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible strains of S. aureus and S. pyogenes. Aleor has been granted a Competitive Generic Therapies (CGT) designation for this ANDA and it is eligible for 180 days of CGT exclusivity as it is the first approved applicant.

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