CDER New January 14, 2015

What's New on the FDA Drugs Site

January 13, 2015

• Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Safety Podcast: FDA has reviewed possible risks of pain medicine use during pregnancy
• National Drug Code Directory

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New and Generic Drug Approvals

January 12, 2015

 

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Activella	estradiol; norethindrone acetate	Tablet;Oral	Amneal Pharms Llc	Manufacturing Change or Addition
Atripla	efavirenz; emtricitabine; tenofovir disoproxil fumarate	Tablet;Oral	Gilead	Manufacturing Change or Addition
Caverject Impulse	alprostadil	Injectable;Injection	Pharmacia and Upjohn	Manufacturing Change or Addition
Cayston	aztreonam	For Solution;Inhalation	Gilead	Manufacturing Change or Addition
Cleocin T	clindamycin phosphate	Gel;Topical	Pharmacia and Upjohn	Manufacturing Change or Addition
Desogen	desogestrel; ethinyl estradiol	Tablet;Oral-21	Organon Usa Inc	Manufacturing Change or Addition
Desogen	desogestrel; ethinyl estradiol	Tablet;Oral-28	Organon Usa Inc	Manufacturing Change or Addition
Desonate	desonide	Gel;Topical	Bayer Hlthcare	Manufacturing Change or Addition
Dextrose 5% In Sodium Chloride 0.9% In Plastic Container	dextrose; sodium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Emend	aprepitant	Capsule;Oral	Merck	Manufacturing Change or Addition
Emend	fosaprepitant dimeglumine	Powder;Intravenous	Merck and Co Inc	Manufacturing Change or Addition
Ganirelix Acetate	ganirelix acetate	Injectable;Injection	Organon Usa Inc	Manufacturing Change or Addition
Humulin N	insulin susp isophane recombinant human	Injectable;Injection	Lilly	Manufacturing Change or Addition
Metrogel	metronidazole	Gel;Topical	Galderma Labs Lp	Manufacturing Change or Addition
Metrolotion	metronidazole	Lotion;Topical	Galderma Labs Lp	Labeling Revision
Potassium Chloride 0.15% In Sodium Chloride 0.45% In Plastic Container	potassium chloride; sodium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Potassium Chloride 0.15% In Sodium Chloride 0.9% In Plastic Container	potassium chloride; sodium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Potassium Chloride 0.224% In Sodium Chloride 0.9%	potassium chloride; sodium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Potassium Chloride 0.3% and Sodium Chloride 0.9% In Plastic Container	potassium chloride; sodium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Pregnyl	gonadotropin, chorionic	Injectable;Injection	Organon Usa Inc	Manufacturing Change or Addition
Reglan	metoclopramide hydrochloride	Tablet;Oral	Ani Pharms	Manufacturing Change or Addition
Revatio	sildenafil citrate	For Suspension;Oral	Pfizer	Manufacturing Change or Addition
Sodium Chloride 0.9% and Potassium Chloride 0.075% In Plastic Container	potassium chloride; sodium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Sodium Lactate 0.167 Molar In Plastic Container	sodium lactate	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Sodium Phosphates In Plastic Container	sodium phosphate, dibasic, heptahydrate; sodium phosphate, monobasic, anhydrous	Injectable;Injection	Hospira	Manufacturing Change or Addition
Vagifem	estradiol	Tablet;Vaginal	Novo Nordisk Inc	Manufacturing Change or Addition
Ventolin Hfa	albuterol sulfate	Aerosol, Metered;Inhalation	Glaxosmithkline	Manufacturing Change or Addition

 

 

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— Thursday, January 15, 2015 — Add Comment