1. Scrip
  2. >>Business

Approval Might Be The Least Of Aralez's Challenges With Yosprala

 
• By Joseph Haas

If the aspirin/omeprazole finally gets approved on its third FDA review, Aralez then will face the challenge of positioning a prescription product against generic, over-the counter versions of both of its main components.

Canadian specialty firm Aralez Pharmaceuticals Inc. is confident that its heart attack and stroke-prevention combination product Yosprala will gain FDA approval on a third review, but that will only be the beginning of the company's challenge as it attempts to position the controlled-release formulation of aspirin and omeprazole against generic and over-the-counter products.

Yosprala combines aspirin with the proton pump inhibitor omeprazole (AstraZeneca PLC's Prilosec and generics) to improve tolerability. Aralez's predecessor Pozen Inc. received two FDA complete response letters due to...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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 Business

All Over For iTeos But Applause For Plan To Return Cash Fast

 
• By Kevin Grogan

The company has moved quickly to wind down operations after its anti-TIGIT pact with GSK collapsed.

Loss Of Exclusivity Product Launches To Fuel Aurobindo’s FY26 Europe Growth

 
• By Vibha Ravi

Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now

Korea Q1 Roundup: Mixed Earnings, Gearing For Possible US Tariffs

 
• By Jung Won Shin

South Korean biopharma companies report a mostly solid first quarter, marked by US growth for original drugs, with several also making preparations for possible US pharma tariffs.

In Brief: Nicox Extends Cash Runway As Kowa Advances NCX 470 In Japan

 
• By Sushmita Panda

Eye drug is already in Phase III trials elsewhere, with results due in Q3. Nicox could earn up to a further €24.5m in milestones and royalties from Kowa alliance.

More from Scrip

Loss Of Exclusivity Product Launches To Fuel Aurobindo’s FY26 Europe Growth

 
• By Vibha Ravi

Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now

Korea Q1 Roundup: Mixed Earnings, Gearing For Possible US Tariffs

 
• By Jung Won Shin

South Korean biopharma companies report a mostly solid first quarter, marked by US growth for original drugs, with several also making preparations for possible US pharma tariffs.

In Brief: Nicox Extends Cash Runway As Kowa Advances NCX 470 In Japan

 
• By Sushmita Panda

Eye drug is already in Phase III trials elsewhere, with results due in Q3. Nicox could earn up to a further €24.5m in milestones and royalties from Kowa alliance.