Drug Approval | March 29, 2023
Zydus receives final approval from USFDA for Loperamide Hydrochloride Capsules
Loperamide Hydrochloride Capsules USP, 2 mg had annual sales of US $34.7 million in the United States
Loperamide Hydrochloride Capsules USP, 2 mg had annual sales of US $34.7 million in the United States
Valbenazine Capsules (RLD Ingrezza) had estimated annual sales of USD 1,235 million in the U.S. (IQVIA MAT December 2022).
The company is addressing these observations
The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin’s marketed products worldwide
Doxepin Hydrochloride capsule is indicated to treat mental/mood problems such as depression and anxiety
Lubiprostone capsule is indicated to treat certain types of constipation (chronic idiopathic constipation and irritable bowel syndrome with constipation)
Obeticholic Acid Tablets (RLD Ocaliva) had estimated annual sales of US $255 million in the US (IQVIA MAT December 2022).
Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)
The audit is a pre-approval inspection for three products filed from the facility
Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of US $1,575 million in the US (IQVIA MAT December 2022)
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