1. Generics Bulletin
  2. >>Products
  3. >>Generics

US FDA Requests Ranitidine Removals

Also Encourages Research For Stable Formulations

 
• By Eileen Francis

FDA requests immediate removal of ranitidine OTC and Rx drugs after third-party testing finds contaminant NDMA increases during storage, especially at higher temperatures. CDER Director Janet Woodcock asks firms to reformulate products to be stable as the ingredient remains approved.

Magnifying glass-FDA_418713547_1200.jpg

The US Food and Drug Administration has requested immediate removal of ranitidine-containing drugs from the market while also encouraging the industry to make the products more stable because the ingredient remains approved for use in the US.

After testing found levels of the probable carcinogen N-nitrosodimethylamine (NDMA) increases in ranitidine over time in storage, especially at higher...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Generics

UPC Imposes Wide Cross-Border Injunction On Zentiva In Ofev Patent Clash

 
• By Dean Rudge

The UPC Court of Appeal has signaled that in pharma disputes, being ready to launch can be as risky as actually launching. In a major setback for Zentiva, the court ruled that completing certain steps well before patent expiry amounted to “setting the stage” for infringement.

Hikma Rides Price Gap as Novo’s Ozempic, Wegovy Costs Climb

 
• By Dean Rudge

Hikma is seeing increased US demand for its generic Victoza (liraglutide) after the end of semaglutide compounding lifted prices for Novo Nordisk’s Ozempic and Wegovy. Meanwhile, the company is not for now pursuing semaglutide generics in the US or EU due to patent protection, but is targeting MENA.

Lupin Launches Generic Version Of Lilly’s Discontinued Glucagon In The US

 
• By Urtė Fultinavičiūtė

Alongside biosimilars, Lupin sees injectable products as one of the key growth drivers in the US, as competition for two of its “material” drugs and proposed tariffs are looming over the firm.

Arizonans To Be Offered Up To 80% Discount On Generic Drugs

 
• By Urtė Fultinavičiūtė

Arizona’s governor Katie Hobbs pointed to Trump’s One Big Beautiful Bill and other federal failures as she signed an executive order to increase access to medications in her state.

More from Products

Hikma Rides Price Gap as Novo’s Ozempic, Wegovy Costs Climb

 
• By Dean Rudge

Hikma is seeing increased US demand for its generic Victoza (liraglutide) after the end of semaglutide compounding lifted prices for Novo Nordisk’s Ozempic and Wegovy. Meanwhile, the company is not for now pursuing semaglutide generics in the US or EU due to patent protection, but is targeting MENA.

Lupin Launches Generic Version Of Lilly’s Discontinued Glucagon In The US

 
• By Urtė Fultinavičiūtė

Alongside biosimilars, Lupin sees injectable products as one of the key growth drivers in the US, as competition for two of its “material” drugs and proposed tariffs are looming over the firm.

Arizonans To Be Offered Up To 80% Discount On Generic Drugs

 
• By Urtė Fultinavičiūtė

Arizona’s governor Katie Hobbs pointed to Trump’s One Big Beautiful Bill and other federal failures as she signed an executive order to increase access to medications in her state.