Hot Pursuit     28-Mar-23
Zydus Life gets final USFDA approval for two drugs
The drug maker said that it has received final approval from US Food and Drug Administration (USFDA) for Levothyroxine Sodium injection and Doxepin Hydrochloride capsules.
Levothyroxine Sodium Injection is indicated for the treatment of myxedema coma. The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara (India).

Further, the company has also received final approval for Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg from USFDA. The drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad (India).

The said drug is equivalent to reference listed drug, Sinequan capsules. Doxepin Hydrochloride capsule is recommended for the treatment of Psychoneurotic patients with depression and/or anxiety, Depression and/or anxiety associated with alcoholism and organic disease, and Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.

Doxepin Hydrochloride capsules USP, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg had annual sales of $28.9 million in the United States (IQVIA MAT January 2023).

As on 31 December 2022, the group now has 355 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company's consolidated net profit jumped 24.5% to Rs 622.90 crore on 17.9% rise in net sales to Rs 4,159.80 crore in Q3 FY23 over Q3 FY22.

Shares of Zydus Lifesciences were down 0.40% to Rs 480.35 on the BSE.

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