- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- Fact Check
- Bone Health Fact Check
- Brain Health Fact Check
- Cancer Related Fact Check
- Child Care Fact Check
- Dental and oral health fact check
- Diabetes and metabolic health fact check
- Diet and Nutrition Fact Check
- Eye and ENT Care Fact Check
- Fitness fact check
- Gut health fact check
- Heart health fact check
- Kidney health fact check
- Medical education fact check
- Men's health fact check
- Respiratory fact check
- Skin and hair care fact check
- Vaccine and Immunization fact check
- Women's health fact check
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
USFDA okays Zydus Cadila Ursodiol Capsules, while tentative nod to Linagliptin, Metformin Hydrochloride Tablets
Ahmedabad: Drugmaker, Zydus Cadila, has recently announced that the company has received final approval from the US Food & Drug Administration (USFDA) to market Ursodiol Capsules USP, 300 mg (US RLD: Actigall Capsules).
Ursodiol is in a class of medications called gallstone dissolution agents. It is used to treat people with primary biliary cirrhosis (PBC; an autoimmune liver disease).
The company also received tentative approval from the USFDA to market Linagliptin and Metformin Hydrochloride Tabs (US RLD: Jentadueto Tablets) in the strengths of 2.5 mg/500 mg, 2.5 mg/850 mg, and 2.5 mg/1,000 mg.
It is used along with diet and exercise to improve control of blood sugar levels in adults with type 2 diabetes mellitus.
Both drugs will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.
The group now has 307 approvals and has so far filed over 390 ANDAs since the commencement of the filing process in FY 2003-04.
Read also: Zydus Cadila gets USFDA okay for Fingolimod Capsules, Verapamil Hydrochloride Injection
Zydus Cadila is a global pharmaceutical company headquartered in Ahmedabad, India.
The company discovers, develops, manufactures, and markets a broad range of healthcare therapies.
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751