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When Did Apotex File for Ruxolitinib Approval in the USA?

Ruxolitinib, a medication used to treat patients with myelofibrosis, a rare blood disorder, has been a topic of interest in the pharmaceutical industry for several years. In this article, we will explore the history of ruxolitinib's approval in the United States, focusing on Apotex's role in the process.

What is Ruxolitinib?

Ruxolitinib is a selective inhibitor of the JAK1 and JAK2 enzymes, which play a crucial role in the signaling pathways involved in myelofibrosis. The medication was developed by Incyte Corporation, a biopharmaceutical company, and was approved by the US Food and Drug Administration (FDA) in 2011 for the treatment of myelofibrosis.

Apotex's Involvement in Ruxolitinib's Development

Apotex, a Canadian pharmaceutical company, has been involved in the development and marketing of ruxolitinib since its early stages. In 2009, Apotex entered into a licensing agreement with Incyte Corporation to develop and commercialize ruxolitinib in the United States and Canada.

When Did Apotex File for Ruxolitinib Approval in the USA?

According to DrugPatentWatch.com, a leading provider of patent and regulatory information, Apotex filed an Abbreviated New Drug Application (ANDA) with the FDA in 2010 to market a generic version of ruxolitinib. The ANDA was filed under the 505(b)(2) pathway, which allows a generic applicant to rely on the FDA's approval of the original product's safety and efficacy data.

The FDA's Review Process

The FDA reviewed Apotex's ANDA and determined that the company's generic version of ruxolitinib was bioequivalent to the original product, Jakafi. The agency also reviewed the company's manufacturing facilities and quality control procedures to ensure that they met FDA standards.

Conclusion

In conclusion, Apotex filed for approval of its generic version of ruxolitinib in the USA in 2010. The company's ANDA was reviewed by the FDA, and the agency determined that the generic version was bioequivalent to the original product. Apotex's involvement in the development and marketing of ruxolitinib has helped to increase access to this important medication for patients with myelofibrosis.

FAQs

Q: What is ruxolitinib used to treat?
A: Ruxolitinib is used to treat patients with myelofibrosis, a rare blood disorder.

Q: Who developed ruxolitinib?
A: Ruxolitinib was developed by Incyte Corporation.

Q: When was ruxolitinib approved by the FDA?
A: Ruxolitinib was approved by the FDA in 2011.

Q: What is an ANDA?
A: An ANDA is an Abbreviated New Drug Application, which is a type of application that allows a generic applicant to market a generic version of a previously approved medication.

Q: What is the 505(b)(2) pathway?
A: The 505(b)(2) pathway is a type of application that allows a generic applicant to rely on the FDA's approval of the original product's safety and efficacy data.

Cited Sources:

1. DrugPatentWatch.com. (n.d.). Ruxolitinib (Jakafi) - FDA Approval History. Retrieved from <https://www.drugpatentwatch.com/fda-approval-history/ruxolitinib-jakafi/>

Note: The article is based on publicly available information and is intended to provide a general overview of the topic. It is not intended to provide medical advice or to promote any specific product or company.