FDA approval for Cladribine to treat active Hairy Cell Leukemia

NewsGuard 100/100 Score

American Pharmaceutical Partners, Inc. today announced it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Cladribine Injection.

Cladribine is indicated for the treatment of active Hairy Cell Leukemia, and is the generic equivalent of Ortho Biotech's Leustatin(R) Injection.

APP expects to commence marketing cladribine in the third quarter of this year. "Sales of cladribine were approximately $9 million in 2003," said Patrick Soon-Shiong, M.D., chairman, president and chief executive officer of American Pharmaceutical Partners. "Cladribine adds to our broad oncology product offering and brings to three the number of ANDA approvals APP has received thus far in 2004."

American Pharmaceutical Partners, Inc. is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets. APP has acquired the exclusive North American rights to manufacture and market ABRAXANE(TM), a proprietary nanoparticle injectable oncology product that has completed Phase III clinical trials for metastatic breast cancer and for which the FDA has granted "Fast Track" designation. The NDA submission was completed in March 2004.

The company believes that it has established the only commercial scale protein-engineered nanoparticle manufacturing capability in the United States. For more information, visit APP's website at http://www.appdrugs.com.


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Scientists map all yeast proteins across cell cycle for the first time