Zydus Lifesciences gets USFDA nod to market generic drug

The company has received the final approval for Levothyroxine Sodium for Injection in strength of 100 mcg/vial, 200 mcg/vial, and 500 mcg/vial from the US Food and Drug Administration (USFDA), said Zydus Lifesciences in a statement.

Levothyroxine Sodium Injection is indicated for the treatment of myxedema coma.

Zydus said the drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara (India).

On Tuesday, Zydus Lifesciences said it has received approval from the US health regulator to market a generic product which is used to treat myxedema coma.

The company has received the final approval for Levothyroxine Sodium for Injection in strength of 100 mcg/vial, 200 mcg/vial, and 500 mcg/vial from the US Food and Drug Administration (USFDA), the drug firm said in a statement.

Levothyroxine Sodium Injection is indicated for the treatment of myxedema coma.

Zydus said the drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara (India).

Zydus Lifesciences Ltd on Friday reported a 24.48 per cent rise in consolidated net profit at ₹622.9 crore for the third quarter ended December 31, 2022.

The company had posted a consolidated net profit of ₹500.4 crore in the same period last fiscal, Zydus Lifesciences Ltd said in a regulatory filing.

Consolidated total revenue from operations during the quarter under review stood at ₹4,362.3 crore, as against ₹3,639.8 crore in the year-ago period, it added.

Total expenses in the third quarter were higher at ₹3,620.7 crore, as compared to ₹3,096.3 crore in the corresponding period last fiscal.

In the third quarter, its business in India comprising formulations as well as consumer wellness registered revenues of ₹1,643.6 crore, up 13 per cent, while the US formulations business registered revenues of ₹1,925 crore, up 29 per cent from the year-ago period, the company said.

Shares of the company were trading 0.19 per cent up at ₹483.20 apiece on the BSE.