Zydus Gets Final Approvals From USFDA To Market Generic Drugs
Zydus Lifescienceson Tuesday informed that it has received final approval for two drugs from the United States Food and Drug Administration (USFDA) including Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg equivalent of US Reference Listed Drug, Sinequan Capsules and Levothyroxine Sodium for Injection, 100 mcg/vial, 200 mcg/vial, and 500 mcg/vial, the pharma company said in a regulatory filing.
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.
The company stated that the drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India). And the drug had annual sales of USD 28.9 million in the United States according to IQVIA MAT January 2023 data.
Whereas Levothyroxine Sodium Injection is indicated for the treatment of myxedema coma and the drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara (India), the company's regulatory filing read.
The company's stock was trading 0.05 per cent lower at Rs 482.05 per scrip on BSE as of 13:36 IST.
