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Alembic Pharma gets US FDA nod for Xylocaine pain relief ointment

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

Press Trust of India  |  New Delhi 

The company already enjoys a 67-68 per cent share of the respiratory drugs market in India and has potential for a 14-15 per cent growth

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," said in a BSE filing.

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

Quoting IQVIA data, said Lidocaine ointment has an estimated market size of $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.

Shares of Alembic Pharmaceuticals were trading 0.54 per cent higher at Rs 563 apiece on BSE.

First Published: Mon, November 26 2018. 12:20 IST
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