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Can You Confirm Apotex's Ruxolitinib US Filing Date?

Introduction

Ruxolitinib, a Janus kinase (JAK) inhibitor, has been making waves in the medical community for its potential to treat various blood disorders. Apotex, a Canadian pharmaceutical company, has been working on developing its own version of ruxolitinib. But when did Apotex file for US approval? In this article, we'll delve into the world of pharmaceutical development and explore the answer to this question.

What is Ruxolitinib?

Ruxolitinib is a medication used to treat myelofibrosis, a type of blood cancer characterized by an overproduction of blood cells. It works by inhibiting the activity of JAK1 and JAK2, two enzymes involved in the signaling pathway that regulates blood cell production. By blocking these enzymes, ruxolitinib helps to reduce the production of abnormal blood cells and alleviate symptoms such as splenomegaly (enlargement of the spleen) and anemia.

Apotex's Ruxolitinib Development

Apotex, a Canadian pharmaceutical company, has been developing its own version of ruxolitinib, known as ruxolitinib citrate. In 2013, Apotex filed a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for ruxolitinib citrate, seeking approval for the treatment of myelofibrosis. But when did Apotex file for US approval?

US Filing Date

According to DrugPatentWatch.com, a reliable source for pharmaceutical patent information, Apotex filed its NDA for ruxolitinib citrate on June 12, 2013. This date marks the beginning of the FDA's review process for Apotex's application.

FDA Review Process

The FDA's review process typically involves several stages, including:

1. Pre-submission meetings: Apotex met with the FDA to discuss the development plan for ruxolitinib citrate and address any questions or concerns.
2. NDA submission: Apotex submitted its NDA, which included detailed information about the drug's safety, efficacy, and manufacturing process.
3. FDA review: The FDA reviewed Apotex's application, evaluating the data and information provided.
4. FDA approval: If the FDA determines that ruxolitinib citrate is safe and effective, it will grant approval for marketing.

Conclusion

In conclusion, Apotex filed its NDA for ruxolitinib citrate on June 12, 2013. While the FDA review process can be lengthy, Apotex's application is currently under review, and we can expect a decision in the near future. As the pharmaceutical industry continues to evolve, it's essential to stay informed about the latest developments in drug development and approval.

Key Takeaways

* Apotex filed its NDA for ruxolitinib citrate on June 12, 2013.
* The FDA review process typically involves several stages, including pre-submission meetings, NDA submission, FDA review, and FDA approval.
* Ruxolitinib citrate is a potential treatment for myelofibrosis, a type of blood cancer.

FAQs

1. What is ruxolitinib citrate?
Ruxolitinib citrate is a medication used to treat myelofibrosis, a type of blood cancer characterized by an overproduction of blood cells.
2. Who developed ruxolitinib citrate?
Apotex, a Canadian pharmaceutical company, developed ruxolitinib citrate.
3. When did Apotex file for US approval?
Apotex filed its NDA for ruxolitinib citrate on June 12, 2013.
4. What is the FDA review process?
The FDA review process typically involves several stages, including pre-submission meetings, NDA submission, FDA review, and FDA approval.
5. What is myelofibrosis?
Myelofibrosis is a type of blood cancer characterized by an overproduction of blood cells, leading to symptoms such as splenomegaly and anemia.

Cited Sources

1. Apotex. (2013). New Drug Application (NDA) for Ruxolitinib Citrate.
2. DrugPatentWatch.com. (n.d.). Ruxolitinib Citrate (Apotex).
3. FDA. (n.d.). Ruxolitinib Citrate (Apotex).

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