Alembic Pharmaceuticals’ 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 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 today.
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 $97 million for the 12 months ended 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. Shares of Alembic Pharmaceuticals were trading 0.54 per cent higher at Rs 563 apiece on the BSE.