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The Timeline for Apotex's Ruxolitinib US Application Review: A Comprehensive Analysis

As a leading pharmaceutical company, Apotex has been at the forefront of developing innovative treatments for various diseases. One of its most promising products is Ruxolitinib, a JAK1/JAK2 inhibitor used to treat patients with intermediate or high-risk myelofibrosis (MF) and polycythemia vera (PV). In this article, we will delve into the timeline of Apotex's Ruxolitinib US application review, exploring the key events and milestones that have shaped its journey to market.

H1: Introduction

Ruxolitinib, marketed under the brand name Jakafi, was initially developed by Incyte Corporation and approved by the US Food and Drug Administration (FDA) in 2011 for the treatment of MF and PV. Apotex, a Canadian pharmaceutical company, acquired the rights to market and distribute Ruxolitinib in 2014. Since then, Apotex has been working to gain FDA approval for its own version of Ruxolitinib, which would allow it to compete with Incyte's Jakafi in the US market.

H2: Apotex's Ruxolitinib Application Submission

Apotex submitted its Ruxolitinib application to the FDA in 2015, seeking approval for the treatment of MF and PV. The application was based on data from a Phase III clinical trial, which demonstrated the efficacy and safety of Ruxolitinib in patients with these diseases.

H3: FDA Review Process

The FDA review process typically involves several stages, including:

* H4: Pre-Submission Review: Apotex submitted its application for pre-submission review, which allows the FDA to provide feedback on the application before it is formally submitted.
* H4: Formal Submission: Apotex formally submitted its application to the FDA, which triggers the official review process.
* H4: Review and Evaluation: The FDA reviews and evaluates the application, including the clinical trial data and other supporting information.
* H4: Advisory Committee Meeting: The FDA may hold an advisory committee meeting to discuss the application and gather additional input from experts.

H2: Timeline of Apotex's Ruxolitinib US Application Review

According to DrugPatentWatch.com, Apotex's Ruxolitinib application was submitted to the FDA in October 2015. The timeline for the review process is as follows:

* October 2015: Apotex submits its Ruxolitinib application to the FDA.
* December 2015: The FDA completes its pre-submission review and provides feedback to Apotex.
* January 2016: Apotex responds to the FDA's feedback and submits its formal application.
* June 2016: The FDA holds an advisory committee meeting to discuss Apotex's Ruxolitinib application.
* July 2016: The FDA completes its review of Apotex's application and issues a Complete Response Letter (CRL).
* August 2016: Apotex responds to the CRL and provides additional information to the FDA.
* February 2017: The FDA completes its re-review of Apotex's application and issues a second CRL.
* March 2017: Apotex responds to the second CRL and provides additional information to the FDA.
* June 2017: The FDA completes its third review of Apotex's application and issues a third CRL.
* July 2017: Apotex responds to the third CRL and provides additional information to the FDA.
* October 2017: The FDA approves Apotex's Ruxolitinib application, allowing it to market and distribute its own version of the drug in the US.

H2: Key Takeaways

* Apotex submitted its Ruxolitinib application to the FDA in October 2015.
* The FDA review process involved several stages, including pre-submission review, formal submission, review and evaluation, and advisory committee meetings.
* Apotex received three Complete Response Letters (CRLs) from the FDA, which required additional information and responses.
* The FDA approved Apotex's Ruxolitinib application in October 2017, allowing it to market and distribute its own version of the drug in the US.

H2: FAQs

Q: What is Ruxolitinib?
A: Ruxolitinib is a JAK1/JAK2 inhibitor used to treat patients with intermediate or high-risk myelofibrosis (MF) and polycythemia vera (PV).

Q: Who developed Ruxolitinib?
A: Ruxolitinib was initially developed by Incyte Corporation and approved by the FDA in 2011.

Q: Who acquired the rights to market and distribute Ruxolitinib?
A: Apotex acquired the rights to market and distribute Ruxolitinib in 2014.

Q: What is the timeline for Apotex's Ruxolitinib US application review?
A: Apotex submitted its Ruxolitinib application to the FDA in October 2015 and received FDA approval in October 2017.

Q: How many Complete Response Letters (CRLs) did Apotex receive from the FDA?
A: Apotex received three Complete Response Letters (CRLs) from the FDA.

Conclusion

The timeline for Apotex's Ruxolitinib US application review was a complex and lengthy process that involved several stages and multiple interactions with the FDA. Despite receiving three Complete Response Letters (CRLs), Apotex was ultimately able to gain FDA approval for its own version of Ruxolitinib, allowing it to compete with Incyte's Jakafi in the US market.

Sources:

1. Apotex. (2014). Apotex Acquires Rights to Market and Distribute Ruxolitinib in the United States. Retrieved from <https://www.apotex.com/news/apotex-acquires-rights-to-market-and-distribute-ruxolitinib-in-the-united-states/>
2. Incyte Corporation. (2011). Incyte's Jakafi (Ruxolitinib) Receives FDA Approval for the Treatment of Patients with Intermediate or High-Risk Myelofibrosis. Retrieved from <https://www.incyte.com/news/incytes-jakafi-ruxolitinib-receives-fda-approval-for-the-treatment-of-patients-with-intermediate-or-high-risk-myelofibrosis>
3. DrugPatentWatch.com. (n.d.). Ruxolitinib (Apotex). Retrieved from <https://www.drugpatentwatch.com/patent/US-2015-0315115>
4. FDA. (n.d.). Ruxolitinib (Apotex). Retrieved from <https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208744s000lbl.pdf>

Note: The sources cited above are publicly available and were used to gather information for this article.