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Sustol Approval History

Sustol (granisetron) is a long-acting 5-HT3 antagonist indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.

Granisetron was first approved by the FDA in 1993 and is available generically in oral tablet and injection formulations.

Sustol injection is administered by a healthcare practitioner subcutaneously over 20 to 30 seconds. It is given in combination with dexamethasone at least 30 minutes before the start of chemotherapy, on the first day of the chemotherapy cycle. The long acting formulation is intended to last at least five days, covering both the acute and delayed phases of CINV.

Common side effects include injection site reactions (infections, bruising, pain, tenderness), constipation, fatigue, headache, diarrhea, abdominal pain, insomnia, dyspepsia, dizziness, asthenia, and gastroesophageal reflux.

Development History and FDA Approval Process for Sustol

Aug 10, 2016Approval Heron Therapeutics Announces FDA Approval of Sustol (granisetron) Extended-Release Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting
Apr 18, 2016Heron Therapeutics Provides Update on FDA Review of Sustol NDA
Mar  3, 2016Heron Therapeutics Provides Update on Sustol NDA
Jan 15, 2016Heron Therapeutics Notified by FDA That It Will Not Take Action on Sustol New Drug Application by the PDUFA Date
Jan 27, 2014Heron Therapeutics Provides Update on Sustol Resubmission
Apr  2, 2013FDA Rejects A.P. Pharma's Cancer Drug
Mar 29, 2013A.P. Pharma Receives FDA Complete Response Letter for APF530
Oct 16, 2012A.P. Pharma Announces PDUFA Action Date for APF530 New Drug Application Resubmission
Apr 25, 2011A.P. Pharma Provides Regulatory Update on APF530 NDA
Mar 19, 2010A.P. Pharma Receives FDA Complete Response Letter for APF530
Jul 20, 2009A.P. Pharma Announces FDA Acceptance of APF530 New Drug Application for Chemotherapy-Induced Nausea and Vomiting
May 18, 2009A.P. Pharma Submits New Drug Application for APF530 in Chemotherapy-Induced Nausea and Vomiting

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