FDA Gives ANDA Status to Vinorelbine for its Indication in Unresectable, Advanced Non Small Cell Lung Cancer
Apr 20, 2005, 09:17, Reviewed by: Dr.
|Vinorelbine Tartrate is indicated as a single agent or in combination with cisplatin for the first line treatment of ambulatory patients with unresectable, advanced non small cell lung cancer (NSCLC). In patients with Stage IV NSCLC, vinorelbine tartrate is indicated as a single agent or in combination with cisplatin. In Stage III NSCLC, vinorelbine tartrate is indicated in combination with cisplatin.
American Pharmaceutical Partners, Inc. (Nasdaq: APPX - News) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of Vinorelbine Tartrate Injection, 10 mg (base)/mL, the generic equivalent of GlaxoSmithKline's NavelbineŽ. According to IMS, sales of vinorelbine tartrate were approximately $61 million in 2004. The company expects to commence marketing this product in the near term.
Vinorelbine Tartrate is indicated as a single agent or in combination with cisplatin for the first line treatment of ambulatory patients with unresectable, advanced non small cell lung cancer (NSCLC). In patients with Stage IV NSCLC, vinorelbine tartrate is indicated as a single agent or in combination with cisplatin. In Stage III NSCLC, vinorelbine tartrate is indicated in combination with cisplatin.
"Vinorelbine represents APP's first ANDA approval in 2005 and is an important addition to our broad oncology product offering," said Al Heller, president and chief executive officer. "While the market for vinorelbine is competitive, we hope to leverage our position as a leading provider of generic oncology products."
- U.S. Food and Drug Administration (FDA)
About American Pharmaceutical Partners
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. Abraxis Oncology, the proprietary division of APP, is devoted entirely to developing and promoting innovative, next-generation cancer therapies such as ABRAXANE(TM), recently launched for the treatment of metastatic breast cancer. For more information, visit APP's website at www.appdrugs.com and www.abraxisoncology.com.
This press release contains forward-looking statements within the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. All statements included or incorporated by reference in this press release, other than statements that are purely historical, are forward-looking statements. The words "may," "will," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "continue," and similar expressions identify forward-looking statements. Forward-looking statements also include the assumptions underlying or relating to any forward-looking statements.
Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, the ability to successfully market Vinorelbine Tartrate, the difficulty in predicting the timing or outcome of other product research and development efforts, potential product characteristics and indications, marketing approvals and launches of other products, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, the ability to successfully manufacture products in a time-sensitive and cost effective manner, the acceptance and demand of new pharmaceutical products, the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in the Company's Form 10-K for the year ended December 31, 2003 and other documents filed by the Company with the Securities and Exchange Commission.
The forward-looking statements in this press release reflect the Company's judgment as of the date of this press release. The Company disclaims any intent or obligation to update these forward-looking statements.
NavelbineŽ is a registered trademark of GlaxoSmithKline PLC.
For any corrections of factual information, to contact the editors or to send
any medical news or health news press releases, use
Top of Page