CDER New July 28, 2017

What's New on the FDA Drugs Site

July 27, 2017

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Atenolol Tablets (New - Currently in Shortage)
  • Azithromycin Tablets (New - Discontinuation)
  • Sertraline Hydrochloride Tablets (New - Discontinuation)
  • Spironolactone Tablets (New - Discontinuation)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

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New and Generic Drug Approvals

July 27, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Abilify Maintena Kit NDA #202971	Aripiprazole	For Suspension, Extended Release; Intramuscular	SUPPL-10	Otsuka Pharm Co Ltd	Efficacy	Approved
Aciphex Sprinkle NDA #204736	Rabeprazole Sodium	Capsule, Delayed Release; Oral	SUPPL-8	Fsc Therap	Labeling	Approved
Apriso NDA #022301	Mesalamine	Capsule, Extended Release; Oral	SUPPL-9	Valeant Pharms Intl	Labeling	Approved
Asacol Hd NDA #021830	Mesalamine	Tablet, Delayed Release; Oral	SUPPL-11	Apil	Labeling	Approved
Asacol NDA #019651	Mesalamine	Tablet, Delayed Release; Oral	SUPPL-27	Apil	Labeling	Approved
Canasa NDA #021252	Mesalamine	Suppository; Rectal	SUPPL-23	Forest Labs Llc	Labeling	Approved
Delzicol NDA #204412	Mesalamine	Capsule, Delayed Release; Oral	SUPPL-8	Apil	Labeling	Approved
Keytruda BLA #125514	Pembrolizumab	Powder, For Injection Solution, Lyophilized Powder	SUPPL-19	Merck Sharp Dohme	Labeling	Approved
Keytruda BLA #125514	Pembrolizumab	Powder, For Injection Solution, Lyophilized Powder	SUPPL-19	Merck Sharp Dohme	Labeling	Approved
Keytruda BLA #125514	Pembrolizumab	Powder, For Injection Solution, Lyophilized Powder	SUPPL-23	Merck Sharp Dohme	Labeling	Approved
Lialda NDA #022000	Mesalamine	Tablet, Delayed Release; Oral	SUPPL-16	Shire	Labeling	Approved
Minoxidil (For Men) ANDA #208092	Minoxidil	Aerosol, Foam; Topical	ORIG-2	Watson Labs Inc		Approved
Pentasa NDA #020049	Mesalamine	Capsule, Extended Release; Oral	SUPPL-30	Shire	Labeling	Approved
Rowasa NDA #019618	Mesalamine	Enema; Rectal	SUPPL-23	Mylan Speciality Lp	Labeling	Approved
Rowasa NDA #019618	Mesalamine	Enema; Rectal	SUPPL-23	Mylan Speciality Lp	Labeling	Approved
Sfrowasa NDA #019618	Mesalamine	Enema; Rectal	SUPPL-23	Mylan Speciality Lp	Labeling	Approved
Sfrowasa NDA #019618	Mesalamine	Enema; Rectal	SUPPL-23	Mylan Speciality Lp	Labeling	Approved
Ultravist 150 NDA #020220	Iopromide	Injectable; Injection	SUPPL-43	Bayer Hlthcare	Labeling	Approved
Ultravist 240 NDA #020220	Iopromide	Injectable; Injection	SUPPL-43	Bayer Hlthcare	Labeling	Approved
Ultravist 300 In Plastic Container NDA #020220	Iopromide	Injectable; Injection	SUPPL-43	Bayer Hlthcare	Labeling	Approved
Ultravist 300 NDA #020220	Iopromide	Injectable; Injection	SUPPL-43	Bayer Hlthcare	Labeling	Approved
Ultravist 370 NDA #020220	Iopromide	Injectable; Injection	SUPPL-43	Bayer Hlthcare	Labeling	Approved

July 26, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Cipro In Dextrose 5% In Plastic Container NDA #019857	Ciprofloxacin	Injectable; Injection	SUPPL-66	Bayer Hlthcare	Labeling	Approved
Cipro NDA #019537	Ciprofloxacin Hydrochloride	Tablet; Oral	SUPPL-87	Bayer Hlthcare	Labeling	Approved
Cipro NDA #020780	Ciprofloxacin	For Suspension; Oral	SUPPL-44	Bayer Hlthcare	Labeling	Approved
Cipro Xr NDA #021473	Ciprofloxacin; Ciprofloxacin Hydrochloride	Tablet, Extended Release; Oral	SUPPL-38	Bayer Hlthcare	Labeling	Approved
Exemestane ANDA #209208	Exemestane	Tablet; Oral	ORIG-1	Upsher-Smith Labs		Approved
Fycompa NDA #202834	Perampanel	Tablet; Oral	SUPPL-12	Eisai Inc	Efficacy	Approved
Fycompa NDA #208277	Perampanel	Suspension; Oral	SUPPL-1	Eisai Inc	Efficacy	Approved
Naloxone Hydrochloride ANDA #207634	Naloxone Hydrochloride	Injectable; Injection	ORIG-1	Somerset Theraps Llc		Approved
Nityr NDA #209449	Nitisinone	Tablet; Oral	ORIG-1	Cycle Pharms Ltd	Type 5 - New Formulation or New Manufacturer	Approved
Olopatadine Hydrochloride ANDA #206046	Olopatadine Hydrochloride	Solution/Drops; Ophthalmic	ORIG-1	Cipla Ltd		Approved
Qnasl NDA #202813	Beclomethasone Dipropionate	Aerosol, Metered; Nasal	SUPPL-11	Teva Branded Pharm	Labeling	Approved
Qnasl NDA #202813	Beclomethasone Dipropionate	Aerosol, Metered; Nasal	SUPPL-11	Teva Branded Pharm	Labeling	Approved
Vibra-Tabs NDA #050533	Doxycycline Hyclate	Tablet; Oral	SUPPL-45	Pfizer	Labeling	Approved
Vibramycin NDA #050006	Doxycycline	For Suspension; Oral	SUPPL-89	Pfizer	Labeling	Approved
Vibramycin NDA #050007	Doxycycline Hyclate	Capsule; Oral	SUPPL-32	Pfizer	Labeling	Approved
Vibramycin NDA #050442	Doxycycline Hyclate	Injectable; Injection	SUPPL-20	Pfizer	Labeling	Approved
Vibramycin NDA #050480	Doxycycline Calcium	Suspension; Oral	SUPPL-56	Pfizer	Labeling	Approved
Victoza NDA #022341	Liraglutide Recombinant	Solution; Subcutaneous	SUPPL-29	Novo Nordisk Inc	REMS	Approved

 

 

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