Alembic Pharma JV Aleor Derma receives USFDA nod for Mupirocin Cream by admin- Wednesday, November 17th, 2021 03:07:37 PM
Alembic Pharmaceuticals announced that its joint challenge Aleor Dermaceuticals Ltd (Aleor) has acquired final approval from america Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Mupirocin Cream USP, 2%. The accepted ANDA is therapeutically equal 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 stressful pores and skin lesions (up to ten cm in duration or 100 cm2 in vicinity) because of susceptible . Lines of S. Aureus and S. Pyogenes. Aleor has been granted a Competitive Generic Therapies (CGT) designation for this ANDA and it’s far eligible for a hundred and eighty days of CGT exclusivity as it’s far the primary authorized applicant.
Mupirocin Cream USP, 2% has an envisioned marketplace size of US$ 28 million for one year finishing Jun 2021 in step with IQVIA.