FDA Drug Safety Communication for Healthcare Professionals: Abnormal heart
FDA Approves Xolair as First and Only Medicine for Children and
Ondansetron is FDA approved to prevent nausea and vomiting only from certain chemotherapy, radiation, and after surgery
FDA approves first drug to prevent severe food allergic reactions
ZOFRAN® (ondansetron hydrochloride) injection, for intravenous or intramuscular use
Zofran is the trade name for ondansetron
Zofran (Ondansetron) Tablets Company: Glaxo Wellcome Inc
These Prior Approval supplemental new drug applications provide for updates to section
It is approved, effective on the date of this letter, for use as recommended in
Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H carbazol-4-one, monohydrochloride, dihydrate
161))
Specifically, the drug is prescribed for: adults receiving chemotherapy The Food and Drug Administration (FDA or the Agency) has determined that ZOFRAN ODT (ondansetron) orally disintegrating tablets, 4 milligrams (mg) and 8 mg, were not withdrawn from sale for reasons of safety or effectiveness
The FDA approved BARHEMSYS based on evidence from 4 clinical trials of 2323 patients undergoing surgery or experiencing nausea and vomiting after the surgery
Ondansetron works ZOFRAN is approved for patients aged 6 months and older
2 Lactation 8
Teva Pharmaceutical had won FDA approval to market generic versions of ondansetron injections in single 4-mg/2-mL doses and in multiple doses in
An important component of the FDA approval of APONVIE were results from two multicenter, randomized, double-blind clinical studies comparing oral aprepitant to current standard of care, IV ondansetron, for the prevention of PONV in patients during the 48 hours following open abdominal surgery demonstrating that aprepitant was more
Z Liu, H Fang, W Tong