CDER New September 14, 2015

What's New on the FDA Drugs Site

September 11, 2015

• Drug Interactions with Hormonal Contraceptives; Public Health and Drug Development Implications; Public Meeting, November 9, 2015, FDA White Oak Campus, 10903 New Hampshire Avenue, Bldg. 31 Conference Center, Section A of the Great Room (Rm. 1503), Silver Spring, MD 20993. Meeting informaiton

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New and Generic Drug Approvals

September 10, 2015

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Acanya	benzoyl peroxide; clindamycin phosphate	Gel;Topical	Dow Pharm	Manufacturing Change or Addition
Adriamycin Rdf	doxorubicin hydrochloride	Injectable;Injection	Pharmacia and Upjohn	Manufacturing Change or Addition
Aptiom	eslicarbazepine acetate	Tablet;Oral	Sunovion Pharms Inc	Manufacturing Change or Addition
Bravelle	urofollitropin	Injectable;Intramuscular, Subcutaneous	Ferring	Manufacturing Change or Addition
Children's Zyrtec Allergy	cetirizine hydrochloride	Syrup;Oral	Mcneil Consumer	Manufacturing Change or Addition
Children's Zyrtec Hives Relief	cetirizine hydrochloride	Syrup;Oral	Mcneil Consumer	Manufacturing Change or Addition
Choletec	technetium tc-99m mebrofenin kit	Injectable;Injection	Bracco	Manufacturing Change or Addition
Chorionic Gonadotropin	gonadotropin, chorionic	Injectable;Injection	Fresenius Kabi Usa	Manufacturing Change or Addition
Condylox	podofilox	Solution;Topical	Actavis Labs Ut Inc	Manufacturing Change or Addition
Cyclessa	desogestrel; ethinyl estradiol	Tablet;Oral-28	Organon Usa Inc	Manufacturing Change or Addition
Diclegis	doxylamine succinate; pyridoxine hydrochloride	Tablet, Delayed Release;Oral	Duchesnay	Manufacturing Change or Addition
Differin	adapalene	Gel;Topical	Galderma Labs Lp	Manufacturing Change or Addition
Famvir	famciclovir	Tablet;Oral	Novartis	Manufacturing Change or Addition
Fludeoxyglucose F18	fludeoxyglucose f-18	Injectable;Intravenous	Feinstein	Manufacturing Change or Addition
Follistim Aq	follitropin alfa/beta	Injectable;Subcutaneous	Organon Usa Inc	Manufacturing Change or Addition
Genotropin	somatropin recombinant	Injectable;Injection	Pharmacia and Upjohn	Manufacturing Change or Addition
Genotropin Preservative Free	somatropin recombinant	Injectable;Injection	Pharmacia and Upjohn	Manufacturing Change or Addition
Humalog	insulin lispro recombinant	Injectable;Injection	Lilly	Manufacturing Change or Addition
Humalog Kwikpen	insulin lispro recombinant	Injectable;Injection	Lilly	Manufacturing Change or Addition
Humalog Pen	insulin lispro recombinant	Injectable;Injection	Lilly	Manufacturing Change or Addition
Invokamet	canagliflozin; metformin hydrochloride	Tablet;Oral	Janssen Pharms	Efficacy Supplement with Clinical Data to Support
Invokana	canagliflozin	Tablet;Oral	Janssen Pharms	Efficacy Supplement with Clinical Data to Support
Karbinal Er	carbinoxamine maleate	Suspension, Extended Release;Oral	Tris Pharma Inc	Manufacturing Change or Addition
Marqibo Kit	vincristine sulfate	Injectable, Liposomal;Intravenous	Talon Therap	Manufacturing Change or Addition
Mdp-Bracco	technetium tc-99m medronate kit	Injectable;Injection	Bracco	Manufacturing Change or Addition
Neupro	rotigotine	Film, Extended Release;Transdermal	Ucb Inc	Manufacturing Change or Addition
Nicorette	nicotine polacrilex	Gum, Chewing;Buccal	Glaxosmithkline	Manufacturing Change or Addition
Nicorette (Mint)	nicotine polacrilex	Gum, Chewing;Buccal	Glaxosmithkline	Manufacturing Change or Addition
Onexton	benzoyl peroxide; clindamycin phosphate	Gel;Topical	Dow Pharm	Manufacturing Change or Addition
Oxycontin	oxycodone hydrochloride	Tablet, Extended Release;Oral	Purdue Pharma Lp	Manufacturing Change or Addition
Potassium Chloride 20meq In Sodium Chloride 0.9% In Plastic Container	potassium chloride; sodium chloride	Injectable;Injection	Hospira	Manufacturing Change or Addition
Potassium Chloride 40meq In Sodium Chloride 0.9% In Plastic Container	potassium chloride; sodium chloride	Injectable;Injection	Hospira	Manufacturing Change or Addition
Pradaxa	dabigatran etexilate mesylate	Capsule;Oral	Boehringer Ingelheim	Labeling Revision
Salagen	pilocarpine hydrochloride	Tablet;Oral	Eisai Inc	Manufacturing Change or Addition
Savaysa	edoxaban tosylate	Tablet;Oral	Daiichi Sankyo	Labeling Revision
Tenormin	atenolol	Tablet;Oral	Alvogen Ipco Sarl	Manufacturing Change or Addition
Tobrex	tobramycin	Ointment;Ophthalmic	Alcon	Manufacturing Change or Addition
Topicort	desoximetasone	Spray;Topical	Taro	Manufacturing Change or Addition
Triferic	ferric pyrophosphate citrate	Solution;Iv (Infusion)	Rockwell Medical Inc	Manufacturing Change or Addition
Xarelto	rivaroxaban	Tablet; Oral	Janssen Pharms	Labeling Revision
Xofigo	radium ra-223 dichloride	Solution;Intravenous	Bayer Hlthcare	Manufacturing Change or Addition

 

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— Monday, September 14, 2015 — Add Comment