Natco Pharma gets USFDA approval for Tipiracil Hydrochloride and Trifluridine Tablets

The US Food and Drug Administration (USFDA) granted final approval to the abbreviated new drug application (ANDA) for Tipiracil Hydrochloride and Trifluridine Tablets, the generic version of Lonsurf sold in the US by Taiho Oncology Inc, Natco said in a regulatory filing.

Natco Pharma gets USFDA approval for Tipiracil Hydrochloride and Trifluridine Tablets
"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," it added, image- Pixabay

Natco Pharma Ltd on Friday said it has received final approval from the US health regulator for its generic Tipiracil Hydrochloride and Trifluridine tablets indicated primarily for the treatment of colorectal cancer.

The US Food and Drug Administration (USFDA) granted final approval to the abbreviated new drug application (ANDA) for Tipiracil Hydrochloride and Trifluridine Tablets, the generic version of Lonsurf sold in the US by Taiho Oncology Inc, Natco said in a regulatory filing.

"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," it added.

Lonsurf had generated annual sales of USD 211 million in the US during the 12-month period ended December 2022, the company said citing IQVIA data.

Catch latest stock market updates here. For all other news related to business, politics, tech, sports and auto, visit Zeebiz.com.

 

Get Latest Business News, Stock Market Updates and Videos; Check your tax outgo through Income Tax Calculator and save money through our Personal Finance coverage. Check Business Breaking News Live on Zee Business Twitter and Facebook. Subscribe on YouTube.

RECOMMENDED STORIES

https://www.zeebiz.com/personal-finance/photo-gallery-power-of-compounding-interest-mutual-fund-sip-retirement-corpus-planning-calculator-how-many-years-it-will-take-to-reach-inr-rs-30000000-with-4000-5000-and-6000-monthly-investment-market-linked-return-324325

Power of Compounding: How many years will it take to reach Rs 3 crore corpus if your monthly SIP is Rs 4,000, Rs 5,000, or Rs 6,000

https://www.zeebiz.com/markets/stocks/photo-gallery-irctc-dividend-record-date-2024-latest-news-record-date-ex-date-irctc-share-price-nse-bse-324434

IRCTC Dividend 2024: Railway PSU announces 200% interim dividend - Check record date and other details

https://www.zeebiz.com/personal-finance/news-sip-mutual-fund-power-of-compounding-retirement-corpus-planning-calculator-salary-inr-rs-25000-per-month-is-it-possible-to-create-over-26367030-fund-calculations-324366

Power of Compounding: Salary Rs 25,000 per month; is it possible to create over Rs 2.60 crore corpus; understand it through calculations

https://www.zeebiz.com/personal-finance/news-reduce-home-loan-emi-or-reduce-tenure-rs-75-lakh-25-year-home-loan-which-option-can-save-rs-25-lakh-and-64-months-and-how-know-here-324393

Reduce Home Loan EMI vs Reduce Tenure: Rs 75 lakh, 25-year loan; which option can save Rs 25 lakh and 64 months and how? Know here

https://www.zeebiz.com/personal-finance/photo-gallery-top-7-large-and-mid-cap-sip-mutual-funds-with-highest-best-xirr-returns-in-5-years-no-1-scheme-has-turned-rs-inr-15000-monthly-investment-into-rs-2054384-uti-icici-hdfc-bank-hsbc-quant-motilal-324344

Top 7 Large and Mid Cap Mutual Funds with Best SIP Returns in 5 Years: No. 1 fund has turned Rs 15,000 monthly SIP investment into Rs 20,54,384; know about others

https://www.zeebiz.com/markets/stocks/photo-gallery-stock-to-buy-for-long-term-on-new-year-samvat-2081-by-anil-singhvi-iifl-finance-share-price-target-nse-bse-smallcap-stock-324310

New Year Pick by Anil Singhvi: This smallcap stock can offer up to 75% return in long term - Check targets

https://www.zeebiz.com/markets/stocks/photo-gallery-share-price-target-of-indian-oil-bharat-petroleum-hindustan-petroleum-largecap-psu-stocks-324329

PSU Oil Stocks: Here's what brokerage suggests on these 2 largecap, 1 midcap scrips - Buy, Sell or Hold?

https://www.zeebiz.com/personal-finance/photo-gallery-power-of-compounding-interest-mutual-fund-sip-retirement-corpus-planning-calculator-how-many-years-it-will-take-to-reach-inr-rs-20000000-with-3000-4000-and-5000-monthly-investment-market-linked-return-323948

Power of Compounding: How many years it will take to reach Rs 2 crore corpus if your monthly SIP is Rs 3,000, Rs 4,000, or Rs 5,000

https://www.zeebiz.com/personal-finance/photo-gallery-sbi-pnb-hdfc-bank-3-year-senior-citizen-fd-fixed-deposit-interest-rate-maturity-return-calculator-which-bank-gives-highest-on-inr-rs-500000-investment-state-bank-of-india-punjab-national-guaranteed-return-scheme-324094

Senior Citizen FD: SBI 3-year FD vs PNB 3-year FD vs HDFC Bank 3-year FD; which FD will give highest return on Rs 5 lakh investment

Written By: PTI
Updated: Fri, Jun 16, 2023
05:40 PM IST
Mumbai, PTI
RELATED NEWS
Natco Pharma acquires 40 million shares in eGenesis Inc Natco Pharma acquires 40 million shares in eGenesis Inc
Natco Pharma submits abbreviated new drug application with USFDA for generic cancer drug Natco Pharma submits abbreviated new drug application with USFDA for generic cancer drug
Natco Pharma rises nearly 2% after mid-cap firm submits application for Rimegepant Sulfate tablets to US FDA Natco Pharma rises nearly 2% after mid-cap firm submits application for Rimegepant Sulfate tablets to US FDA

By accepting cookies, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts.

x