Alembic Pharma JV Aleor Derma gets USFDA nod for Mupirocin Cream
Mumbai: Alembic Pharmaceuticals Limited today announced that its joint venture Aleor Dermaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Mupirocin Cream USP, 2%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bactroban Cream, 2%, of...
Mumbai: Alembic Pharmaceuticals Limited today announced that its joint venture Aleor Dermaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Mupirocin Cream USP, 2%.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bactroban Cream, 2%, of SmithKline Beecham(Cork) Ltd, Ireland (SmithKline).
Mupirocin Cream USP, 2% 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.
Read also: Alembic Pharma JV Aleor Derma secures USFDA approval for Metronidazole Gel
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat.
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