Zydus Lifesciences said that it has received final approval from US Food and Drug Administration (USFDA) for Lubiprostone capsules, 8 mcg and 24 mcg.
The said drug is equivalent to reference listed drug, Amitiza capsules. It is indicated to treat certain types of constipation (chronic idiopathic constipation and irritable bowel syndrome with constipation).The drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad (India).
Lubiprostone capsules, 8 mcg and 24 mcg had annual sales of $196.5 million in the United States (IQVIA MAT, January 2023).
Further, the company also received final USFDA approval for Doxepin Hydrochloride capsules USP, 150 mg.
Doxepin Hydrochloride capsule is indicated to treat mental/mood problems such as depression and anxiety. It helps improve moods and feelings of well-being, relieves anxiety and tension, helps sleep better and increases the energy level. The said drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad.
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As on 31 December 2022, the group has 354 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.
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