- 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 approves Lupin Bromfenac Ophthalmic Solution
Bromfenac Ophthalmic Solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
Mumbai: Global pharma major Lupin Limited has announced that the Company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Bromfenac Ophthalmic Solution, 0.07%, to market a generic equivalent of Prolensa Ophthalmic Solution, 0.07%, of Bausch & Lomb Inc.
Lupin is the exclusive first-to-file for this product and is eligible for 180-day exclusivity.
The product will be manufactured at Lupin’s Pithampur facility in India.
Bromfenac Ophthalmic Solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
According to WHO, Cataract is a clouding of the lens in the eye that normally affects vision. Cataract, the most common cause of blindness and visual impairment, is often related to ageing. Occasionally children are born with the condition, or a cataract may develop following an eye injury, or as a result of inflammation or other diseases, such glaucoma and diabetes.
Bromfenac Ophthalmic Solution (RLD Prolensa) had estimated annual sales of USD 185 million in the U.S. (IQVIA MAT September 2023).
Read also: Lupin type 2 diabetes drug Canagliflozin bags USFDA tentative approval
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centers.
Read also: Lupin gets USFDA nod for cholesterol lowering drug Pitavastatin
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