Drug Approval | May 01, 2024
Granules India announced ANDA Approval for Colchicine Capsules
Colchicine Capsules are indicated for prophylaxis of gout flares in adult
Colchicine Capsules are indicated for prophylaxis of gout flares in adult
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)
Very strong revenue and EPS growth in the first quarter coupled with exciting pipeline delivery
Mirabegron Extended-Release Tablets, 25 mg had estimated annual sales of US$ 1,019 million in the US
Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market
Pemetrexed Injection is used as a drug, in the treatment of non-small cell lung cancer in combination with other chemotherapy agents
Submission based on results from pivotal phase III trial showing all primary endpoints met
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
Global Phase-3 study initiation expected in the second half of 2024
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