Alembic Pharma arm get USFDA final nod for Lidocaine & Prilocaine cream USP by admin- Tuesday, April 12th, 2022 04:32:27 PM
Alembic Pharmaceuticals announced that its thoroughly owned subsidiary, Aleor Dermaceuticals Ltd (Aleor) has acquired final approval from the USA Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lidocaine and Prilocaine Cream USP, 2.5%/2.Five%. The authorized ANDA is therapeutically equivalent to the reference indexed drug product (RLD) EMLA Cream, 2.5%/2.Five%, of Teva Branded Pharmaceutical Products R&D, Inc. Lidocaine 2.Five% and Prilocaine 2.Five% cream (a eutectic combination of lidocaine 2.Five% and prilocaine 2.Five%) is indicated as a topical anesthetic to be used on regular intact pores and skin for neighborhood .Analgesia and genital mucous membranes for superficial minor surgical operation and as pretreatment for infiltration anesthesia. Lidocaine 2.5% and Prilocaine 2.5% cream is not endorsed in any medical state of affairs while penetration or migration past the tympanic membrane into the middle ear is possible due to the
ototoxic outcomes found in animal studies.