Biotech Calendar: Key FDA Action Dates

Vion Pharmaceuticals(VION.OB)
Drug/indication: Onrigin for acute myelogenous leukemia
FDA decision date: Dec. 12

If approved, Onrigin would be used to induce remission in elderly AML patients.

Now, an updates of recently announced FDA approval decisions:

Savient Pharmaceuticals(SVNT)
Drug/indication: Krystexxa for gout
FDA decision date: Aug. 1

The FDA declined to approve Krystexxa, citing concerns about the way the drug is manufactured. The FDA rejection came despite a recommendation for approval from an advisory panel in June. Savient plans to respond to the FDA's concerns in early 2010.

BioDelivery Sciences(BDSI)
Drug/indication: Onsolis for breakthrough cancer pain
FDA decision date: June 15

The FDA approved Onsolis on July 16.

AMAG Pharmaceuticals(AMAG)
Drug/Indication: Feraheme for anemia due to chronic kidney disease
FDA decision date: June 26

The FDA approved Feraheme on June 30.

Labopharm(DDSS)
Drug/indication: DDS-04A for depression
FDA decision date: July 18

The FDA declined to approve DDS-04A on July 20, citing problems found during an inspection of the drug's manufacturing plant. Labopharm is working to address and correct the manufacturing issues and will submit a response to the FDA.

United Therapeutics(UTHR)
Drug/indication: Tyvaso for pulmonary arterial hypertension
FDA decision date: July 30

The FDA approved Tyvaso on July 30.

Advanced Life Sciences(ADLS.OB)
Drug/indication: Restanza for community-acquired pneumonia
FDA decision date: July 31

The FDA rejected Restanza on July 31. The company said it will need to conduct a new clinical trial in order to get the drug approved.

-- Reported by Adam Feuerstein in Boston

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