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12th April 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that its wholly owned subsidiary, Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lidocaine and Prilocaine Cream USP, 2.5%/2.5%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) EMLA Cream, 2.5%/2.5%, of Teva Branded Pharmaceutical Products R&D, Inc. Lidocaine 2.5% and Prilocaine 2.5% cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) 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. Lidocaine 2.5% and Prilocaine 2.5% cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies
Lidocaine and Prilocaine Cream USP, 2.5%/2.5% has an estimated market size of US$29 million for twelve months ending Dec. 2021 according to IQVIA.
Alembic has received a cumulative total of 163 ANDA approvals (140 final approvals and 23 tentative approvals) from USFDA.