Drug Approval | February 18, 2023
Zydus receives final approval from USFDA for Sirolimus Tablets, 1 mg and 2 mg
Sirolimus Tablets had annual sales of USD 69 million in the United States (IQVIA MAT Dec. 2022)
Sirolimus Tablets had annual sales of USD 69 million in the United States (IQVIA MAT Dec. 2022)
According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza Tablets, 2.5 mg and 5 mg market achieved annual sales of approximately US $122.3 million
Themis will market this drug with the brand name REMITHEM.
Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya
The respective product approval is based on Revlimid Capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg as a reference product
The approval for Glycopyrrolate clears the path for more internally manufactured injectable products
The Tc 99m Mertiatide Injection is used in the diagnosis of congenital and acquired renal abnormalities
DETAF would be a welcome new addition in the management of HIV infections and will be available for supplies to low- and middle-income countries
Granules now have a total of 53 ANDA approvals from USFDA
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