Alembic receives FDA confirmation for generic Bactroban
Alembic’s joint venture Aleor Dermaceuticals has obtained the Food and Drug Administration’s permission for Mupirocin Cream 2%.
The product is the generic of SmithKline Beecham’s Bactroban cream.
[Read more: Alembic obtains FDA nod for 2 generics]
It 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 designation and is eligible for 180 days of CGT exclusivity as it is the first approved applicant.
[Read more: Alembic gets FDA blessing for generic Macrodantin]
Mupirocin cream has an estimated market size of $28 million for the 12 months ending June 2021, according to IQVIA.