美国FDA最新批准上市的药物（2014年度）目录更新 - 新药热点

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美国FDA最新批准上市的药物（2014年度）目录更新

2014-07-29 15:53:27 来源: 作者: 【大中小】浏览:1209次评论:0条

June 5, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Alsuma¹	sumatriptan succinate	Injectable;Subcutaneous	Meridian Medcl	Labeling Revision
Complera²	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	Tablet;Oral	Gilead Sciences Inc	Labeling Revision
Exparel³	bupivacaine	Injectable, Liposomal;Injection	Pacira Pharms Inc	Manufacturing Change or Addition
Fioricet W/ Codeine⁴	acetaminophen; butalbital; caffeine; codeine phosphate	Capsule;Oral	Watson Labs Inc	Manufacturing Change or Addition
Invokana⁵	canagliflozin	Tablet;Oral	Janssen Pharms	Manufacturing Change or Addition
Lioresal⁶	baclofen	Injectable;Intrathecal	Medtronic Neuro	Manufacturing Change or Addition
Lovaza⁷	omega-3-acid ethyl esters	Capsule;Oral	Smithkline Beecham	Manufacturing Change or Addition
Methoxsalen⁸	methoxsalen	Capsule;Oral	Strides Arcolab Ltd	Approval
Oxycodone Hydrochloride⁹	oxycodone hydrochloride	Solution;Oral	Coastal Pharms	Approval
Procardia Xl¹⁰	nifedipine	Tablet, Extended Release;Oral	Pfizer	Manufacturing Change or Addition
Risperdal Consta¹¹	risperidone	Injectable;Intramuscular	Janssen Pharms	Manufacturing Change or Addition
Septocaine¹²	articaine hydrochloride; epinephrine bitartrate	Injectable;Injection	Deproco	Manufacturing Change or Addition
Sodium Chloride 0.45% In Plastic Container¹³	sodium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Container¹⁴	sodium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Suboxone¹⁵	buprenorphine hydrochloride; naloxone hydrochloride	Film;Sublingual	Reckitt Benckiser	Manufacturing Change or Addition
Voltaren¹⁶	diclofenac sodium	Tablet, Delayed Release;Oral	Novartis	Manufacturing Change or Addition
Voltaren-Xr¹⁷	diclofenac sodium	Tablet, Extended Release;Oral	Novartis	Manufacturing Change or Addition

June 4, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Amitriptyline Hydrochloride¹⁸	amitriptyline hydrochloride	Tablet;Oral	Accord Hlthcare Inc	Approval
Byetta¹⁹	exenatide synthetic	Injectable;Subcutaneous	Astrazeneca Ab	Manufacturing Change or Addition
Cefepime In Plastic Container²⁰	cefepime hydrochloride	Injectable;Injection	Baxter Hlthcare	Labeling Revision
Cevimeline Hydrochloride²¹	cevimeline hydrochloride	Capsule;Oral	Pack Pharms Llc	Approval
Elidel²²	pimecrolimus	Cream;Topical	Valeant Bermuda	Manufacturing Change or Addition
Fortesta²³	testosterone	Gel, Metered;Transdermal	Endo Pharms	Manufacturing Change or Addition
Humalog²⁴	insulin lispro recombinant	Injectable;Injection	Lilly	Manufacturing Change or Addition
Humalog Kwikpen²⁵	insulin lispro recombinant	Injectable;Injection	Lilly	Manufacturing Change or Addition
Humalog Mix 50/50²⁶	insulin lispro protamine recombinant; insulin lispro recombinant	Injectable;Injection	Lilly	Manufacturing Change or Addition
Humalog Mix 50/50 Kwikpen²⁷	insulin lispro protamine recombinant; insulin lispro recombinant	Injectable;Injection	Lilly	Manufacturing Change or Addition
Humalog Mix 50/50 Pen²⁸	insulin lispro protamine recombinant; insulin lispro recombinant	Injectable;Injection	Lilly	Manufacturing Change or Addition
Humalog Mix 75/25²⁹	insulin lispro protamine recombinant; insulin lispro recombinant	Injectable;Injection	Lilly	Manufacturing Change or Addition
Humalog Mix 75/25 Kwikpen³⁰	insulin lispro protamine recombinant; insulin lispro recombinant	Injectable;Injection	Lilly	Manufacturing Change or Addition
Humalog Mix 75/25 Pen³¹	insulin lispro protamine recombinant; insulin lispro recombinant	Injectable;Injection	Lilly	Manufacturing Change or Addition
Humalog Pen³²	insulin lispro recombinant	Injectable;Injection	Lilly	Manufacturing Change or Addition
Humulin 70/30³³	insulin recombinant human; insulin susp isophane recombinant human	Injectable;Injection	Lilly	Manufacturing Change or Addition
Humulin 70/30 Pen³⁴	insulin recombinant human; insulin susp isophane recombinant human	Injectable;Injection	Lilly	Manufacturing Change or Addition
Humulin N³⁵	insulin susp isophane recombinant human	Injectable;Injection	Lilly	Manufacturing Change or Addition
Levothyroxine Sodium³⁶	levothyroxine sodium	Injectable; Injection	Fresenius Kabi Usa	Manufacturing Change or Addition
Levothyroxine Sodium³⁷	levothyroxine sodium	Powder;Intravenous	Fresenius Kabi Usa	Manufacturing Change or Addition
Prandimet³⁸	metformin hydrochloride; repaglinide	Tablet;Oral	Novo Nordisk Inc	Manufacturing Change or Addition
Prolia³⁹	denosumab	Injectable; Subcutaneous	Amgen	Labeling Revision
Vimpat⁴⁰	lacosamide	Tablet;Oral	Ucb Inc	Manufacturing Change or Addition
Vogelxo⁴¹	testosterone	Gel; Transdermal	Upsher Smith Labs	Approval
Xgeva⁴²	denosumab	Injectable; Subcutaneous	Amgen	Labeling Revision

June 3, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Cortenema⁴³	hydrocortisone	Enema;Rectal	Ani Pharms	Manufacturing Change or Addition
Increlex⁴⁴	mecasermin recombinant	Injectable;Subcutaneous	Ipsen Inc	Labeling Revision
K-Tab⁴⁵	potassium chloride	Tablet, Extended Release;Oral	Abbvie	Manufacturing Change or Addition
Nithiodote⁴⁶	sodium nitrite; sodium thiosulfate	Solution, Solution;Intravenous, Intravenous	Hope Pharms	Manufacturing Change or Addition
Oxycodone Hydrochloride⁴⁷	oxycodone hydrochloride	Tablet;Oral	Amneal Pharms	Approval
Potassium Chloride⁴⁸	potassium chloride	Tablet, Extended Release;Oral