NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China
Loperamide Hydrochloride Capsules USP, 2 mg had annual sales of US $34.7 million in the United States
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)
Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)
According to IQVIA sales data for the 12-month period ending January 2023, the Compazine Tablets, 5 mg and 10 mg market achieved annual sales of approximately US $26.9 million
The Phase 3 data presented at AAD include a comprehensive review of the THRIVE-AA2 results and further elaborate the topline data reported in August 2022
Cleocin Hydrochloride Capsules market achieved annual sales of approximately US $33.6 million
Olanzapine Orally Disintegrating Tablets are used to treat certain mental/mood conditions
The agreement is for USFDA approved Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets
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