Drug Approval | May 13, 2024
Zydus receives final approval from USFDA for Dexamethasone Tablets
Dexamethasone Tablets USP, 1 mg had annual sales of US$ 1.8 mn in the United States (IQVIA MAT March 24)
Dexamethasone Tablets USP, 1 mg had annual sales of US$ 1.8 mn in the United States (IQVIA MAT March 24)
Sevelamer Carbonate Tablets approval consolidates the company's position in the Sevelamer segment
Cellectis is also eligible to receive an investigational new drug (IND) option fee and development
Glenmark’s Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC), will be distributed in the U.S. by Glenmark Therapeutics, USA
The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad (India)
Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market
US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac Tablets of Eli Lilly
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The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.
Lunaphore's flagship COMET technology is the only fully-automated, high-throughput, hyperplex platform with superior tissue profiling capabilities
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