The cream is indicated as a topical anaesthetic for use on normal intact skin for local analgesia and genital mucous membranes for superficial minor surgery
Alembic Pharmaceuticals’ wholly-owned subsidiary, Aleor Dermaceuticals (Aleor) has received final approval from the US Food & Drug Administration (US FDA) 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 per cent/2.5 per cent, of Teva Branded Pharmaceutical Products R&D, 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.
Lidocaine 2.5 per cent and Prilocaine 2.5 per cent 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 $29 million for twelve months ending December 2021 according to IQVIA.
Alembic has received a cumulative total of 163 ANDA approvals (140 final approvals and 23 tentative approvals) from US FDA.
