Alembic Pharmaceuticals Limited (Alembic) announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Mupirocin Cream.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bactroban Cream, 2%, of SmithKline Beecham(Cork) Ltd, Ireland (SmithKline), the announcement added.
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, Alembic informed.
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, the announcement added.
Alembic has received year to date (YTD) 13 approvals (10 final ·approvals and 3 tentative approvals) and a cumulative total of 152 ANDA approvals (133 final approvals and 19 tentative approvals) from USFDA the announcement said.
However the company do not have any plans to launch the Mupirocin cream in the Indian market, an official of the company informed while speaking to Drug Today Medical Times.