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granisetron

Generic: GRANISETRON·Brand: GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISOL, Granisol, KYTRIL, SANCUSO, SUSTOL, Sancuso, Sustol

granisetron: developed by 3 companies · 6 FDA decisions.

granisetron evidence translation

What we can confirm

6 FDA records

What it means

More than one developer is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch for new trials or company disclosures after the FDA record.
BioSniper AIPage evidence connected

Prepared research question

What is verified about granisetron, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

prevention of acute and delayed nausea and vomiting associated with MEC or AC combination chemotherapy regimens

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (3)
CompanyPhase
HERON THERAPEUTICS, INC. /DE/ (HRTX)
prevention of acute and delayed nausea and vomiting associat…
Approved
DR REDDYS LABORATORIES LTD (RDY)Approved
Teva Pharmaceutical Industries Limited (TEVA)Approved
FDA Decisions6 records
Approval1 INDICATIONS AND USAGE SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is a serotonin-3 (5-HT 3 ) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated (HRTX)FDA ↗
NDA022445Type 5 - New Formulation or New ManufacturerStandardSubcutaneousInjectable
ApprovalINDICATIONS AND USAGE Granisetron hydrochloride tablets are indicated for the prevention of: Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.(RDY)FDA ↗
ANDA078846OralTablet
ApprovalINDICATIONS AND USAGE Granisetron hydrochloride tablets are indicated for the prevention of: Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.(RDY)FDA ↗
ANDA077297OtherInjectable
Approval(RDY)FDA ↗
ANDA077165OtherInjectable
ApprovalINDICATIONS AND USAGE Granisetron hydrochloride tablets are indicated for the prevention of: Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.(RDY)FDA ↗
ANDA078392OtherInjectable
ApprovalINDICATIONS AND USAGE Granisetron hydrochloride tablets are indicated for the prevention of: Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.(TEVA)FDA ↗
ANDA078080OralTablet

Frequently asked questions

Who is developing granisetron?

granisetron is being developed by HERON THERAPEUTICS, INC. /DE/, DR REDDYS LABORATORIES LTD, Teva Pharmaceutical Industries Limited.

What is granisetron's latest FDA decision?

The most recent tracked FDA decision for granisetron is Approval for 1 INDICATIONS AND USAGE SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is a serotonin-3 (5-HT 3 ) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated , dated August 9, 2016.