US FDA Approves Lidocaine and Prilocaine Cream of Aleor Dermaceuticals


The company ‘Alembic Pharmaceuticals Limited’ announced that, its wholly owned subsidiary known as Aleor Dermaceuticals Limited has now received a final approval from the Food and Drug Administration (FDA) of the United States for the company’s ANDA (Abbreviated New Drug Application) for the Prilocaine and Lidocaine Cream USP of 2.5 percent/2.5 percent.

The US FDA approced ANDA (Abbreviated New Drug Application) has been therapeutically equivalent to the reference listed drug product (RLD) known as the EMLA Cream, 1.5 percent/2.5 percent of the Teva Branded Pharmaceutical Products R&D, Inc.

The Lidocaine 2.5 percent and the Prilocaine 2.5 percnet cream has been indicated as a topical anaesthetic for the use on the normal intact skin for the genital mucus and local analgesia membranes for the superficial minor surgery and also as a pre-treatment for the infiltration anaesthesia.

The cream has not been recommended in any of the clinical situation when the penetration and migration beyond the tympanic membrane into the middle ear has been possible because of the ototoxic effects that has been observed in the animal studies. The Prilocaine and Lidocaine USP 1.5 percent/2.5 percent is now having an estimated market size of 29 million dollars for around twelve months that has been ending in the month of December 2021.


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