Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets
Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia
Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia
The initiative is focused on a problem that continues to plague cancer outcomes in India
Efdoralprin alfa, a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, showed superior efficacy to standard plasma-derived therapy in adults with AATD
The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,
This marks the first partnership between Pfizer and Cipla in India
If cleared by regulators, CagriSema would become the first treatment to combine a GLP-1 receptor agonist and a long-acting amylin analogue in a single injection
At one year, the drug met its primary and all key secondary endpoints, delivering significantly better weight maintenance than placebo
The combination also outperformed chemotherapy on another important secondary endpoint
The receipt of this permission paves way for the marketing of Datopotamab Deruxtecan powder for concentrate for solution for infusion 100 mg (r-DNA origin) in India
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