Zydus Cadila, one of the leading Indian pharmaceutical companies, announced its tentative approval for its new sitagliptin bases 25, 50 and 100 mg tablets from the United States Food & Drug Administration (FDA).
Zydus’ base contains the active moisture sitagliptine in a form different from the one used in Januvia, the branded reference product (sitagliptin phosphate).
On October 31, 2020, Zydus filed a New Drug Application (NDA) under Section 505(b)(2) of the Federal Food and Drug Cosmetic Act (FD&C Act) with the United States Food and Drug Administration (FDA) seeking approval to market sitagliptin base 25, 50 and 100 mg tablets.
Zydus’ NDA received tentative approval upon completion of the first review cycle on September 2, 2021.ganizing activities like conferences, debates, poster-oral presentations, quiz contests, essay writing competitions etc. in the area of pharmacovigilance a
Antibiotic use has surged globally, leading to a rise in antibiotic resistance, especially concerning in…
Choking is a leading cause of injury and death in young children, particularly those under…
Hard Water (Khara Pani) Leading To Hair Fall Hard water is rich in minerals and…
Discover how the rise in high blood pressure during pregnancy is impacting maternal and fetal…
"Discover the transformative power of six delicious homemade drinks that can help you naturally melt…
"Transform your weight loss routine with these eight delicious fat-flushing drinks that not only hydrate…