USFDA: New and Generic Drug Approvals: 18 SEP 2014

New and Generic Drug Approvals

September 18, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Aloxi	palonosetron hydrochloride	Injectable;Intravenous	Helsinn Hlthcare	Labeling Revision
Aloxi	palonosetron hydrochloride	Capsule;Oral	Helsinn Hlthcare	Labeling Revision
Anzemet	dolasetron mesylate	Tablet;Oral	Sanofi Aventis Us	Labeling Revision
Anzemet	dolasetron mesylate	Injectable;Injection	Sanofi Aventis Us	Labeling Revision
Biltricide	praziquantel	Tablet;Oral	Bayer Hlthcare	Manufacturing Change or Addition
Cefazolin and Dextrose	cefazolin sodium	Injectable;Injection	B Braun	Efficacy Supplement with Clinical Data to Support
Cleocin Phosphate In Dextrose 5% In Plastic Container	clindamycin phosphate	Injectable;Injection	Pharmacia and Upjohn	Manufacturing Change or Addition
Halcion	triazolam	Tablet;Oral	Pharmacia and Upjohn	Labeling Revision
Hydralazine Hydrochloride	hydralazine hydrochloride	Tablet;Oral	Cadila Pharms Ltd	Approval
Megace Es	megestrol acetate	Suspension;Oral	Par Pharm	Labeling Revision
Ofloxacin	ofloxacin	Tablet;Oral	Cadila Pharms Ltd	Approval
Sancuso	granisetron	Film, Extended Release;Transdermal	Prostrakan Inc	Labeling Revision
Trulicity	dulaglutide	Injectable;Injection	Eli Lilly and Co	Approval
Vasostrict	vasopressin	Solution;Iv (Infusion)	Par Sterile Products	Manufacturing Change or Addition
Zofran	ondansetron hydrochloride	Injectable;Injection	Glaxosmithkline	Labeling Revision
Zofran	ondansetron hydrochloride	Tablet;Oral	Glaxosmithkline	Labeling Revision
Zofran	ondansetron hydrochloride	Solution;Oral	Glaxosmithkline	Labeling Revision
Zofran Odt	ondansetron	Tablet, Orally Disintegrating;Oral	Glaxosmithkline	Labeling Revision
Zofran Preservative Free	ondansetron hydrochloride	Injectable;Injection	Glaxosmithkline	Labeling Revision
Zuplenz	ondansetron	Film;Oral	Galena Biopharma Inc	Labeling Revision