CDER New August 9, 2016

What's New on the FDA Drugs Site

 

August 8, 2016

• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

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New and Generic Drug Approvals

August 5, 2016

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Betoptic	betaxolol hydrochloride	Solution/Drops;Ophthalmic	Alcon	Manufacturing Change or Addition
Children's Allegra Allergy	fexofenadine hydrochloride	Tablet, Orally Disintegrating;Oral	Sanofi Aventis Us	Manufacturing Change or Addition
Children's Allegra Hives	fexofenadine hydrochloride	Tablet, Orally Disintegrating;Oral	Sanofi Aventis Us	Manufacturing Change or Addition
Ciloxan	ciprofloxacin hydrochloride	Ointment;Ophthalmic	Alcon Pharms Ltd	Manufacturing Change or Addition
Cleocin Phosphate	clindamycin phosphate	Injectable;Injection	Pharmacia and Upjohn	Labeling Revision
Cleocin Phosphate In Dextrose 5% In Plastic Container	clindamycin phosphate	Injectable;Injection	Pharmacia and Upjohn	Labeling Revision
E-Z-Hd	barium sulfate	For Suspension;Oral	Bracco	Manufacturing Change or Addition
Elocon	mometasone furoate	Ointment;Topical	Merck Sharp Dohme	Manufacturing Change or Addition
Finacea	azelaic acid	Gel;Topical	Bayer Hlthcare	Labeling Revision
Humalog Kwikpen	insulin lispro recombinant	Solution;Subcutaneous	Eli Lilly and Co	Manufacturing Change or Addition
Imatinib Mesylate	imatinib mesylate	Tablet;Oral	Apotex Inc	Approval
Keytruda	pembrolizumab	Powder, For Injection Solution, Lyophilized Powder	Merck Sharp Dohme	Supplement
Maxidex	dexamethasone	Suspension/Drops;Ophthalmic	Alcon	Manufacturing Change or Addition
Mifeprex	mifepristone	Tablet;Oral	Danco Labs Llc	Manufacturing Change or Addition
Monodox	doxycycline	Capsule;Oral	Aqua Pharms	Manufacturing Change or Addition
Orkambi	ivacaftor; lumacaftor	Tablet;Oral	Vertex Pharms Inc	Manufacturing Change or Addition
Prolia	denosumab	Injectable; Subcutaneous	Amgen	Labeling Revision
Votrient	pazopanib hydrochloride	Tablet;Oral	Novartis Pharms Corp	Labeling Revision
Xgeva	denosumab	Injectable; Subcutaneous	Amgen	Labeling Revision

 

 

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— Tuesday, August 9, 2016 — Add Comment