FDA Gives ANDA Status to Vinorelbine for its Indication in Unresectable, Advanced Non Small Cell Lung Cancer
Apr 20, 2005 - 9:16:38 AM

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 Navelbine®. 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."

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