Drug Approval | April 22, 2024
Zydus launches Mirabegron ER Tablets 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
Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market
This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy
Breakthrough Therapy designation for pain associated with DPN granted by FDA
Pemetrexed Injection is used as a drug, in the treatment of non-small cell lung cancer in combination with other chemotherapy agents
Biocon will undertake the development, manufacturing and supply of the drug product, and Biomm will be responsible for obtaining regulatory approval and commercialization in the Brazilian market
Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers
Longest survival follow-up ever reported for immunotherapy treatment in this setting
Submission based on results from pivotal phase III trial showing all primary endpoints met
SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva
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
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