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news.Specialty drug company American Pharmaceutical Partners has received approval from the FDA for its abbreviated new drug application for vinorelbine tartrate injection, the generic equivalent of GlaxoSmithKline's lung cancer therapy, Navelbine.
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Vinorelbine tartrate 10mg (base)/mL 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 and in Stage III NSCLC, vinorelbine tartrate is indicated in combination with cisplatin.
“Vinorelbine represents APP’s first abbreviated new drug application (ANDA) approval in 2005 and is an important addition to our broad oncology product offering,” said Al Heller, president and CEO of American Pharmaceutical Partners. “While the market for vinorelbine is competitive, we hope to leverage our position as a leading provider of generic oncology products.”
American Pharmaceutical Partners said it expects to commence marketing this product soon.