Combination will create a Canadian Health Champion spanning generic, biosimilar and branded pharmaceuticals
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024
Under the arrangement, Dr. Reddy's will have exclusive rights to promote and distribute Sanofi's vaccine brands Hexaxim, Pentaxim, Tetraxim, Menactra, FluQuadri, Adacel and Avaxim 80U
The company is confident of addressing the concern raised by the USFDA
Zydus Lifesciences receives EIR report from USFDA for API Ahmedabad facility
The validations confirm the completion of the applications and commence the scientific review process
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