Zydus Lifesciences Ltd on Thursday said it has received final approval from the US health regulator to manufacture its generic topical anaesthetic Lidocaine and Prilocaine cream. The approval granted by the US Food and Drug Administration (USFDA) for Lidocaine and Prilocaine cream 2.5 per cent/2.5 per cent, Zydus Lifesciences Ltd said in a regulatory filing.
Lidocaine and Prilocaine cream 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, it added.
The cream will be produced at the group’s topical manufacturing site at Changodar, Ahmedabad, it added.
The company said Lidocaine and Prilocaine cream had annual sales of USD 22.05 million in the US as of October 2024 citing IQVIA data.
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