Drug Approval | March 25, 2023
Zydus receives final approval from USFDA for Doxepin Hydrochloride Capsules USP, 150 mg
Doxepin Hydrochloride capsule is indicated to treat mental/mood problems such as depression and anxiety
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)
ZYIL1 is a novel oral small molecule NLRP3 inhibitor which has demonstrated CSF penetration in non-human primates
Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)
The observations are procedural in nature
The company will be submitting the responses to US FDA observations within stipulated timeline
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