Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
Febuxostat tablets had annual sales of USD 32 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022).
Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, (RLD Toviaz®) had estimated annual sales of USD 177 million in the U.S. (IQVIA MAT September 2022).
Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, have an estimated market size of US$ 177 million for twelve months ending Sep 2022
Triazolam tablets are used on a short-term basis to treat insomnia (difficulty falling asleep or staying asleep)
Upon approval, XPHOZAH would be the first and only phosphate absorption inhibitor, offering patients a novel mechanism
If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine
The current approval is first of the many fillings made by the company's CDMO partners from the flagship facility in Bangalore
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