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Biotech Calendar: Key FDA Action Dates

Endo Pharmaceuticals (ENDP)
Drug/indication: Nebido for testosterone replacement
FDA decision date: Sept. 2

Nebido is a long-acting injectable testosterone that Endo picked up when it acquired Indevus Pharmaceuticals.

Spectrum Pharmaceuticals (SPPI)
Drug/indication: Zevalin for non-Hodgkin's lymphoma
FDA decision date: Sept. 7

Spectrum has a new FDA approval decision date following a July 5 request from the agency for additional clinical data. Spectrum submitted that data on July 9. Spectrum is seeking an expansion to the label for Zevalin to include consolidation therapy for patients with NHL. Zevalin is an effective drug that has been a commercial disappointment, so the company hopes the expanded FDA label will boost sales.

Auxilium Pharmaceuticals (AUXL)
Drug/indication: Xiaflex for Dupuytren's contracture
FDA decision date: Aug. 28
FDA advisory panel date: Sept. 16

Xiaflex is designed to dissolve collagen deposits that form cords around joints in the hands and cause the fingers to contract and become inflexible. Notice that the advisory panel's review of Xiaflex is scheduled for after the FDA approval decision date, which likely means a delay.

Theravance (THRX - Get Report)
Drug/indication: Telavancin for bacterial infections
FDA decision date: Sept. 16

The FDA review of telavancin for complicated skin and skin structure infections was delayed by the agency's request for additional information. Theravance is also seeking approval of telavancin for hospital-acquired pneumonia, with a second FDA approval decision date of Nov. 26.

Eurand Pharmaceuticals (EURX)
Drug/indication: Zenpep for pancreatic insufficiency
FDA decision date: Sept. 24

Zenpep is a pancreatic enzyme replacement product for patients with pancreatic insufficiencies, a condition associated with cystic fibrosis, chronic pancreatitis and other diseases.

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