Natco Pharma gets USFDA nod for Tipiracil Hydrochloride and Trifluridine Tablets

Lonsurf is indicated primarily for the treatment of colorectal cancer.;

Published On 2023-06-16 06:09 GMT | Update On 2023-06-16 10:45 GMT

Hyderabad: Natco Pharma Limited has announced final approval for its Abbreviated New Drug Application (ANDA) for Tipiracil Hydrochloride and Trifluridine Tablets (generic for Lonsurf) from the U.S. Food and Drug Administration (USFDA).

Lonsurf is sold in the US by Taiho Oncology Inc.

"Natco believes it is one of the First-to-File for the product and may be eligible for a 180-day exclusivity at the time of launch," the company stated.

Lonsurf is indicated primarily for the treatment of colorectal cancer.

According to World Health Organisation (WHO), Colorectal cancer is the third most common cancer type worldwide; in 2020, almost 2 million cases were diagnosed. Colorectal cancer is the second most common cause of cancer death, leading to almost 1 million deaths per year.

As per IQVIA data, Lonsurf had generated annual sales of $211 million in USA during the twelve months ending December 2022.

Natco Pharma Limited is a vertically integrated and R&D focused pharmaceutical company engaged in developing, manufacturing and marketing of finished dosage formulations (“FDF”) and active pharmaceutical ingredients (“APIs”). The company's focus is primarily on niche therapeutic areas and complex products. It markets and distributes products in over 40 countries. It sells FDF products in the United States, India, Europe and the rest of the world (“RoW”). Natco also operates in certain key geographies through its subsidiaries.

Natco Pharma is also engaged in contract manufacturing business, whereby it undertakes selected contracts with pharmaceutical companies to manufacture and supply pharmaceutical products.

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.

Ruchika Sharma

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

Comments Policy

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 .

Natco Pharma gets USFDA nod for Tipiracil Hydrochloride and Trifluridine Tablets

Lonsurf is indicated primarily for the treatment of colorectal cancer.;

Similar News

Russia's Enteromix Cancer Vaccine Shows 100% Success in Trial, Awaits Final Nod for Public Use

Mankind Pharma wins CDSCO nod to start Phase 1 trials of Autoimmune drug candidate

India seeks to boost drug exports to semi regulated markets in Africa, Latin America, Southeast Asia

Jubilant Ingrevia appoints Sonia Dharap as Vice President - Sales, Business Development (US)

EMA warns of sharp rise in illegal medicines sold in EU

Indegene opens new center in Pune, boosts India presence

Indian medical devices share increased from 10% to 30% of domestic requirements in last 5 years: DoP Secretary

AstraZeneca announces Rs 176 crore investments in India to expand Chennai GITC