Zydus receives tentative approval from USFDA for Enzalutamide Tablets
Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
The product is expected to be launched in Q3FY25
Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for treatment of schizophrenia
Quinidine Sulphate helps manage rare irregular heartbeat conditions
Both the products are Gadolinium based Magnetic Resonance Imaging (MRI) contrast agents and will be the first set of contrast agent products in Zydus’ injectable portfolio for the US market
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug
Mirabegron Extended-Release Tablets, 50 mg is a generic equivalent of Myrbetriq® Extended-Release Tablets, 50 mg of Astellas Pharma Global Development
The company will take all necessary steps to work with USFDA towards earliest remediation of the above facility
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