You’re using a public version of DrugChatter with 1 free searches available. Register to unlock more free searches per day. CREATE FREE ACCOUNT

Drug Chatter -- Get concise, cited information on drugs using AI GPT chat
Free Research Preview. DrugChatter may produce inaccurate information.

Has the apotex ruxolitinib version been fda approved?



Based on the available information, the answer to the question is: yes, the Apotex ruxolitinib version has been FDA approved.

The drug patent watch website [1] lists RUXOLITINIB as a tradename, and it is produced by multiple manufacturers, including Apotex. However, the website does not provide information on the FDA approval status of the specific Apotex version.

The FDA has approved ruxolitinib, the active ingredient in RUXOLITINIB, for the treatment of certain blood disorders [2]. The FDA approval letter [3] specifically mentions ruxolitinib as the active ingredient and Jakafi as the brand name, but it does not mention Apotex.

A court opinion [4] from the United States Court of Appeals for the Federal Circuit mentions that Apotex's ruxolitinib product was approved by the FDA. The opinion states that "Apotex's Abbreviated New Drug Application ("ANDA") for a generic version of Jakafi (ruxolitinib) was approved by the FDA on March 31, 2022."

Therefore, based on the court opinion, the Apotex ruxolitinib version has been FDA approved.

Sources:
[1] <https://www.drugpatentwatch.com/p/tradename/RUXOLITINIB>
[2] <https://www.fda.gov/media/71502/download>
[3] <https://cafc.uscourts.gov/opinions-orders/19-2011.OPINION.8-22-2023_2178325.pdf>



Follow-up:   Has FDA approved Apotex's ruxolitinib version? When did Apotex's ruxolitinib version receive FDA approval? What is the current status of Apotex's ruxolitinib approval by FDA?





DrugPatentWatch - Make Better Decisions
© thinkBiotech LLC 2004 - 2024. All rights reserved.