USFDA approves Aleor Dermaceuticals, Lidocaine and Prilocaine topical cream

Lidocaine 2.5 per cent and Prilocaine 2.5 per cent is indicated as a topical anaesthetic for use on normal intact skin for local analgesia and genital mucous membranes for superficial minor surgery 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 per cent / 2.5 per cent. 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 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 anaesthetic for use on normal intact skin for local analgesia and genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anaesthesia. The 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 per cent / 2.5 per cent, has an estimated market size of US$29 million

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