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 per cent, 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 per cent, of Teva Branded Pharmaceutical Products R&D, Inc, it added.
Lidocaine 2.5 per cent and Prilocaine 2.5 per cent cream — a eutectic mixture of lidocaine 2.5 per cent and prilocaine 2.5 per cent — 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 pre-treatment for infiltration anesthesia, it added.
Citing IQVIA, the company said Lidocaine and Prilocaine Cream 2.5 per cent/2.5 per cent has an estimated market size of USD 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.
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