Alembic Pharma gets USFDA nod for Alembic Pharma

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NEW DELHI: Alembic Pharmaceuticals Monday said its joint venture Aleor Dermaceuticals has received approval from the US health regulator for Xylocaine ointment, used for temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin and insect bites. 

"Aleor Dermaceuticals has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Lidocaine ointment USP, 5 per cent," Alembic Pharmaceuticals said in a BSE filing. 

The approved product is therapeutically equivalent to AstraZeneca Pharmaceuticals' Xylocaine ointment, 5 per cent. 

Quoting IQVIA data, Alembic Pharmaceuticals said Lidocaine ointment has an estimated market size of USD 97 million for twelve months ending December 2017. 

Alembic has a cumulative total of 79 ANDA approvals (66 final approvals and 13 tentative approvals) from USFDA, including this first ANDA approval for Aleor.