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).
Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg in the United States.
Triazolam tablets are used on a short-term basis to treat insomnia (difficulty falling asleep or staying asleep)
Selexipag tablet is indicated in adults for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization for PAH
None of the observations are related to data integrity and management believes that they are addressable
The company will submit an action plan on the observations and will engage with US FDA for next steps.
Silodosin capsules treat signs and symptoms of an enlarged prostate gland
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad
Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)
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