Sun Pharma bags USFDA nod for generic Mesalamine ER capsules to treat bowel disease
Mumbai: Pharma major, Sun Pharmaceutical Industries Limited, has recently announced that the company has received final approval from US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for generic Mesalamine Extended Release Capsules, 500 mg. The capsules are used to treat bowel disease.
The generic product approval is based on Pentasa Extended Release Capsules, 500mg as a reference product.
As per March 2022 IQVIA Health data, Pentasa Extended Release Capsules, 500mg had annualized sales of approximately US$ 213 million in USA.
Read also: Sun Pharma gets CDSCO committee approval for manufacturing Ranibizumab
Sun Pharma is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra. The company manufacture and market a large basket of pharmaceutical formulations covering a broad spectrum of chronic and acute therapies.
It includes generics, branded generics, specialty, complex or difficult to make technology-intensive products, over-the-counter (OTC), antiretrovirals (ARVs), Active Pharmaceutical Ingredients (APIs) and Intermediates.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.