Aleor Dermaceuticals receives USFDA approval for Lidocaine 25Percentage and Prilocaine 25Percentage Cream

20 Apr 2022 , 01:34 AM

Alembic Pharmaceuticals today announced that its wholly owned subsidiary Aleor Dermaceuticals 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 25Percentage25Percentage The approved ANDA is therapeutically equivalent to the reference listed drug product RLD EMLA Cream 25Percentage25Percentage of Teva Branded Pharmaceutical Products RD Inc Lidocaine 25Percentage and Prilocaine 25Percentage cream a eutectic mixture of lidocaine 25Percentage and prilocaine 25Percentage 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 25Percentage and Prilocaine 25Percentage 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 25Percentage25Percentage has an estimated market size of US$29 million for twelve months ending Dec 2021 according to IQVIA