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
Mirabegron Extended-Release Tablets, 25 mg had estimated annual sales of US$ 1,019 million in the US
The US Generics market has been witnessing significant pricing pressure leading to significant losses at Jubilant Cadista since FY2022 onwards.
FDA has concluded that this inspection is 'closed'
Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers
KRKA holds 51% and Laurus Labs holds 49% shareholding
The Product is expected to be the first generic approval on the market
Combination will create a Canadian Health Champion spanning generic, biosimilar and branded pharmaceuticals
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