Alembic Pharmaceuticals joint venture Aleor gets USFDA approval to market Mupirocin cream
The approved abbreviated new drug application (ANDA) for Mupirocin cream is therapeutically equivalent to the reference listed drug product (RLD), Bactroban cream (2 per cent) of SmithKline Beecham (Cork) Ltd, Ireland, the company said.
Alembic Pharmaceuticals on Wednesday said its joint venture Aleor Dermaceuticals Ltd (Aleor) has received approval from the US health regulator to market Mupirocin cream.
The approved abbreviated new drug application (ANDA) for Mupirocin cream is therapeutically equivalent to the reference listed drug product (RLD), Bactroban cream (2 per cent) of SmithKline Beecham (Cork) Ltd, Ireland, the company said.
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Mupirocin cream is indicated for the treatment of secondarily infected traumatic skin lesions 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 exclusivity as it is the first approved applicant, Alembic Pharmaceuticals said in a statement.
According to IQVIA, Mupirocin cream USP, 2 per cent has an estimated market size of USD 28 million for the twelve months ended June 2021.
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