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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

Adam Feuerstein writes regularly for In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.
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