Alembic Pharmaceuticals Ltd on Tuesday said its wholly-owned arm, Aleor Dermaceuticals Ltd, has received final approval from the US health regulator for its generic version of Lidocaine and Prilocaine cream, indicated as a topical anesthetic.
The final approval granted by the US Food & Drug Administration (USFDA) is for its abbreviated new drug application (ANDA) for Lidocaine and Prilocaine cream of strength 2.5 per cent/2.5 percent, Alembic said in a statement.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) EMLA Cream, 2.5 per cent/2.5 percent, of Teva Branded Pharmaceutical Products R&D, Inc, it added.
Lidocaine 2.5 percent and Prilocaine 2.5 percent cream -- a eutectic mixture of lidocaine 2.5 percent and prilocaine 2.5 percent -- is indicated as a topical anesthetic for use on normal intact skin for local analgesia and genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia, it added.
Citing IQVIA, the company said Lidocaine and Prilocaine Cream 2.5 per cent/2.5 percent has an estimated market size of $29 million for twelve months ending December 2021.
Alembic has received a cumulative total of 163 abbreviated new drug application (ANDA) approvals (140 final approvals and 23 tentative approvals) from USFDA.
(With inputs from PTI)
