Drug Approval | April 29, 2024
The USFDA has issued 5 observations pursuant to the completion of audit
The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad (India)
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
Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers
The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations
The company will respond to the Warning Letter within the stipulated timelines
Doxycycline Capsules, 40 mg is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients
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