Alembic Pharma yesterday announced that its wholly owned subsidiary, Aleor Dermaceuticals, has received final approval from the US Food and Drug Administration (FDA) 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 (RLD) product EMLA Cream, 2.5%/2.5%, of Teva Branded Pharmaceutical Products R&D, Alembic Pharma notified in a statement.
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 anaesthesia. 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, the statement added.
It also said that Lidocaine and Prilocaine Cream USP, 2.5%/2.5% has an estimated market size of $29 million for twelve months ending December 2021, according to IQVIA.