Live
- Three persons admitted to hospital for diarrhea treatment
- First Star Outside Milky Way Captured: WOH G64 is 2,000 Times Larger Than the Sun
- Sikkim govt to constitute state Niti Ayog: CM Tamang
- CBI books Rajasthan narcotics inspector for Rs 3 lakh bribe
- Rajasthan bypolls: A tough contest between BJP and Congress
- Albania joins SEPA, paving way for EU integration
- Japanese government approves 250-billion USD economic package to ease price pain
- Six pharma companies to set up their units in Telangana
- The Unstable Events of a 17-Wicket Day in Perth: India vs Australia
- Dutch FM's Israel trip cancelled after Netanyahu's arrest warrant
Zydus gets final approval from US FDA for Type 2 diabetes pills
Indian pharma company Zydus Lifesciences on Friday said that it has received final approval from the US Food and Drug Administration (USFDA) to market tablets for Type 2 diabetes.
Ahmedabad: Indian pharma company Zydus Lifesciences on Friday said that it has received final approval from the US Food and Drug Administration (USFDA) to market tablets for Type 2 diabetes.
The drugmaker said it got “approval for its New Drug Application (NDA) to market Zituvimet XR (sitagliptin and metformin hydrochloride) extended-release tablets”.
With this, Zydus has all three NDAs of Sitagliptin (base) and combination franchise approved, it added.
"Notably, all the three NDAs achieved first-cycle approval (FCA)," the company stated.
Further, it added that the product will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ, India.
According to IQVIA (MAT May 2024), the US market for DPP-IV inhibitors and its combinations is $9.5 bn.
