- 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
Zydus Lifesciences wins USFDA nod for Diclofenac Sodium and Misoprostol Delayed Release Tablets
Diclofenac Sodium and Misoprostol Delayed Release Tablets are used to treat osteoarthritis and rheumatoid arthritis in people at high risk for developing stomach or intestinal ulcers.
Ahmedabad: Zydus Lifesciences Limited has announced that the company has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg (USRLD: Arthrotec Delayed-Release Tablets).
Diclofenac belongs to nonsteroidal anti-inflammatory drug (NSAID) group of medicines. It works by reducing substances in the body that cause pain and inflammation. Misoprostol reduces stomach acid and replaces protective substances in the stomach that are reduced by NSAIDs. Misoprostol protects the lining of the esophagus, stomach and intestines while taking diclofenac.
Diclofenac Sodium and Misoprostol Delayed Release Tablets are used to treat osteoarthritis and rheumatoid arthritis in people at high risk for developing stomach or intestinal ulcers.
Read also: Zydus Lifesciences secures USFDA okay for Esomeprazole Magnesium for Delayed-Release Oral Suspension
The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India).
Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States (IQVIA MAT Mar. 2023). The group now has 373 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.
Read also: Zydus gets USFDA nod for bowel disease drug Balsalazide Disodium
Zydus Lifesciences Limited, Formerly known as Cadila Healthcare Limited, is an Indian Pharmaceutical company headquartered in Ahmedabad. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals. It is primarily engaged in the manufacture of generic drugs.
Read also: Zydus Lifesciences begins Phase IV trial for fatty liver disease drug Saroglitazar Magnesium
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