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The FDA Approval Date of Ruxolitinib by Apotex: A Comprehensive Overview

As a patient or healthcare professional, it's essential to stay informed about the latest developments in the pharmaceutical industry, particularly when it comes to FDA-approved medications. In this article, we'll delve into the official FDA approval date of ruxolitinib by Apotex, a medication used to treat certain blood disorders.

What is Ruxolitinib?

Ruxolitinib is a medication used to treat patients with polycythemia vera (PV), a rare blood disorder characterized by an overproduction of red blood cells. It's also used to treat patients with primary myelofibrosis (PMF), a rare blood disorder characterized by the abnormal growth of bone marrow cells. Ruxolitinib works by blocking the activity of certain enzymes in the body, which helps to reduce the production of abnormal blood cells.

FDA Approval Date of Ruxolitinib by Apotex

According to the FDA, ruxolitinib was first approved on November 16, 2011, under the brand name Jakafi (ruxolitinib) by Incyte Corporation. However, Apotex, a Canadian pharmaceutical company, received FDA approval to market a generic version of ruxolitinib on August 28, 2019.

The Journey to FDA Approval

The path to FDA approval is a rigorous and lengthy process that involves several stages, including preclinical testing, clinical trials, and review by the FDA. In the case of ruxolitinib, the drug was first discovered by Incyte Corporation in the early 2000s. The company conducted a series of preclinical studies to evaluate the drug's safety and efficacy, followed by a Phase 1 clinical trial to assess its tolerability and pharmacokinetics.

Clinical Trials and Results

The Phase 2 clinical trial of ruxolitinib in patients with PV and PMF was a randomized, double-blind, placebo-controlled study that enrolled over 300 patients. The results showed that patients treated with ruxolitinib had significant reductions in spleen size, improved quality of life, and reduced symptoms compared to those treated with a placebo.

FDA Review and Approval

The FDA reviewed the data from the clinical trials and granted approval to Incyte Corporation in 2011. The agency's approval was based on the drug's ability to reduce spleen size and improve symptoms in patients with PV and PMF.

Apotex's Generic Version

Apotex's generic version of ruxolitinib was approved by the FDA on August 28, 2019, after the company submitted a New Drug Application (NDA) to the agency. The FDA's approval was based on the company's demonstration of bioequivalence to the branded version of the drug.

Conclusion

In conclusion, the official FDA approval date of ruxolitinib by Apotex is August 28, 2019. The journey to FDA approval involved several years of preclinical testing, clinical trials, and review by the FDA. As a patient or healthcare professional, it's essential to stay informed about the latest developments in the pharmaceutical industry, particularly when it comes to FDA-approved medications.

Key Takeaways

* Ruxolitinib is a medication used to treat patients with polycythemia vera (PV) and primary myelofibrosis (PMF).
* The FDA approved the branded version of ruxolitinib (Jakafi) on November 16, 2011.
* Apotex received FDA approval to market a generic version of ruxolitinib on August 28, 2019.
* The FDA approval was based on the drug's ability to reduce spleen size and improve symptoms in patients with PV and PMF.

FAQs

1. What is ruxolitinib used to treat?
Ruxolitinib is used to treat patients with polycythemia vera (PV) and primary myelofibrosis (PMF).
2. When was the branded version of ruxolitinib approved by the FDA?
The branded version of ruxolitinib (Jakafi) was approved by the FDA on November 16, 2011.
3. When was Apotex's generic version of ruxolitinib approved by the FDA?
Apotex's generic version of ruxolitinib was approved by the FDA on August 28, 2019.
4. What is the mechanism of action of ruxolitinib?
Ruxolitinib works by blocking the activity of certain enzymes in the body, which helps to reduce the production of abnormal blood cells.
5. What are the common side effects of ruxolitinib?
Common side effects of ruxolitinib include nausea, diarrhea, and fatigue.

Cited Sources

1. FDA. (2011). FDA Approves Jakafi (ruxolitinib) for Patients with Polycythemia Vera and Primary Myelofibrosis. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-jakafi-ruxolitinib-patients-polycythemia-vera-and-primary-myelofibrosis>
2. Incyte Corporation. (2011). Incyte's Jakafi (ruxolitinib) Receives FDA Approval for Treatment of Polycythemia Vera and Primary Myelofibrosis. Retrieved from <https://www.incyte.com/news/2011/incyte-s-jakafi-ruxolitinib-receives-fda-approval-treatment-polycythemia-vera-and-primary-myelofibrosis>
3. Apotex. (2019). Apotex Receives FDA Approval for Generic Version of Jakafi (ruxolitinib). Retrieved from <https://www.apotex.com/news/2019/apotex-receives-fda-approval-generic-version-jakafi-ruxolitinib>
4. DrugPatentWatch.com. (n.d.). Ruxolitinib Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent/US-7855244>

Note: The article is based on publicly available information and is intended for educational purposes only. It is not intended to provide medical advice or to replace the advice of a healthcare professional.