Alembic Pharma Secures USFDA Final Approval for Generic Prucalopride Tablets
Written By : sheeba farhat
Published On 2026-07-28 13:05 GMT | Update On 2026-07-28 13:05 GMT
Advertisement
New Delhi: Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Prucalopride Tablets, 1 mg and 2 mg.
The approved generic product is therapeutically equivalent to Motegrity (Prucalopride) Tablets, 1 mg and 2 mg, marketed by Takeda Pharmaceuticals USA Inc.
Prucalopride is a selective serotonin-4 (5-HT4) receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults. The company advised healthcare professionals to refer to the prescribing information for the complete indication and usage details.
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.