U.S. FDA approval for sitagliptin base for Zydus Cadilla Arm

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

Medically Speaking

Recent Posts

ANTIBIOTIC MISUSE IN INDIA: HOW IT’S MAKING INFECTION TREATMENT MORE CHALLENGING

Antibiotic use has surged globally, leading to a rise in antibiotic resistance, especially concerning in…

6 hours ago

CHILD DIES FROM CHOKING ON CANDY: HOW TO SAFEGUARD AGAINST CHOKING HAZARDS IN YOUNG CHILDREN

Choking is a leading cause of injury and death in young children, particularly those under…

7 hours ago

Video: How Hard Water Leads to Hair Fall and Expert Tips to Combat It

Hard Water (Khara Pani) Leading To Hair Fall Hard water is rich in minerals and…

9 hours ago

“How High Blood Pressure During Pregnancy Is Rising: What Every Expectant Mother Should Know”

Discover how the rise in high blood pressure during pregnancy is impacting maternal and fetal…

9 hours ago

“Revitalize Your Weight Loss Journey: 6 Powerful Homemade Drinks to Naturally Melt Away Fat!”

"Discover the transformative power of six delicious homemade drinks that can help you naturally melt…

9 hours ago

“Revitalize Your Weight Loss Journey: 8 Powerful Fat-Flushing Drinks to Boost Your Results!”

"Transform your weight loss routine with these eight delicious fat-flushing drinks that not only hydrate…

9 hours ago