USFDA: New and Generic Drug Approvals: 10 OCT 2014

New and Generic Drug Approvals

October 10, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Akynzeo	netupitant; palonosetron hydrochloride	Capsule;Oral	Helsinn Hlthcare	Approval
Curosurf	poractant alfa	Suspension;Intratracheal	Chiesi Usa Inc	Labeling Revision
Eligard	leuprolide acetate	Injectable;Subcutaneous	Tolmar Therap	Labeling Revision
Eligard	leuprolide acetate	Injectable;Subcutaneous	Tolmar Therap	Manufacturing Change or Addition
Eligard	leuprolide acetate	Injectable;Subcutaneous	Tolmar Therap	Labeling Revision
Eligard	leuprolide acetate	Injectable;Subcutaneous	Tolmar Therap	Labeling Revision
Eligard	leuprolide acetate	Injectable;Subcutaneous	Tolmar Therap	Labeling Revision
Harvoni	ledipasvir; sofosbuvir	Tablet;Oral	Gilead Sciences Inc	Approval
Isentress	raltegravir potassium	Tablet;Oral	Merck Sharp Dohme	Manufacturing Change or Addition
Lumason	sulfur hexafluoride lipid-type a microspheres	Suspension;Injectable	Bracco	Approval
Naftin	naftifine hydrochloride	Cream;Topical	Merz Pharms	Efficacy Supplement with Clinical Data to Support
Naftin	naftifine hydrochloride	Gel;Topical	Merz Pharms	Supplement
Prozac	fluoxetine hydrochloride	Capsule;Oral	Eli Lilly and Co	Efficacy Supplement with Clinical Data to Support
Sarafem	fluoxetine hydrochloride	Capsule;Oral	Eli Lilly and Co	Efficacy Supplement with Clinical Data to Support
Soliris	eculizumab	Injectable; Iv (Infusion)	Alexion Pharm	Supplement
Symbyax	fluoxetine hydrochloride; olanzapine	Capsule;Oral	Lilly	Efficacy Supplement with Clinical Data to Support
Verelan Pm	verapamil hydrochloride	Capsule, Extended Release;Oral	Alkermes Gainesville	Labeling Revision