http://www.drugs.com/newdrugs.html New drug approvals news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals. en http://www.drugs.com/newdrugs/fda-approves-xgeva-giant-cell-tumor-bone-3815.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss June 13, 2013 -- The U.S. Food and Drug Administration today expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor. GCTB generally... Thu, 13 Jun 2013 22:06:39 GMT http://www.drugs.com/newdrugs/new-fluzone-quadrivalent-four-strain-influenza-vaccine-sanofi-pasteur-now-licensed-fda-broad-age-3810.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss • The first and only 4-strain influenza vaccine option for patients as young as six months of age, • Helps protect children and adults against additional influenza B strain, • Newest addition to the Fluzone family of... Tue, 11 Jun 2013 12:06:01 GMT http://www.drugs.com/newdrugs/fda-approves-revlimid-lenalidomide-patients-relapsed-refractory-mantle-cell-lymphoma-3806.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss SUMMIT, N.J.--(BUSINESS WIRE)--Jun. 5, 2013-- Celgene Corporation today announced the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental new drug application (sNDA) for Revlimid (lenalidomide) for the treatment of... Wed, 05 Jun 2013 20:06:06 GMT http://www.drugs.com/newdrugs/flamel-technologies-announces-fda-approval-bloxiverz-3802.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss LYON, FRANCE -- (Marketwire) -- 06/03/2013 -- Flamel Technologies today announced that the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for Bloxiverz (neostigmine methylsulfate), a drug used... Tue, 04 Jun 2013 00:06:31 GMT http://www.drugs.com/newdrugs/fda-approves-mekinist-trametinib-advanced-melanoma-3798.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss May 29, 2013 -- GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved Mekinist (trametinib) as a single-agent oral treatment for unresectable or metastatic melanoma in adult patients with BRAF V600E or... Thu, 30 May 2013 00:05:20 GMT http://www.drugs.com/newdrugs/fda-approves-tafinlar-dabrafenib-advanced-melanoma-3797.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss May 29, 2013 -- GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved Tafinlar (dabrafenib). Tafinlar is indicated as a single-agent oral treatment for unresectable melanoma (melanoma that cannot be... Thu, 30 May 2013 00:05:16 GMT http://www.drugs.com/newdrugs/fda-approves-xofigo-advanced-prostate-cancer-3790.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss May 15, 2013 -- The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is... Thu, 16 May 2013 00:05:39 GMT http://www.drugs.com/newdrugs/fda-approves-simponi-ulcerative-colitis-3789.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss May 15, 2013 -- The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis. Simponi works by blocking tumor necrosis factor (TNF), which plays an... Wed, 15 May 2013 23:05:50 GMT http://www.drugs.com/newdrugs/arbor-pharmaceuticals-announces-fda-approval-nymalize-3785.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss May 13, 2013 - Atlanta, GA - Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Nymalize (nimodipine) oral solution. Nymalize was previously granted Orphan... Tue, 14 May 2013 00:05:22 GMT http://www.drugs.com/newdrugs/fda-approves-breo-ellipta-chronic-obstructive-pulmonary-copd-3782.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss May 10, 2013 -- The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive... Fri, 10 May 2013 20:05:52 GMT http://www.drugs.com/newdrugs/ilaris-approved-fda-active-systemic-juvenile-idiopathic-arthritis-3779.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss Basel, May 10, 2013 - Novartis announced today that the US Food and Drug Administration (FDA) has approved Ilaris (canakinumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older. Ilaris is... Fri, 10 May 2013 12:05:57 GMT http://www.drugs.com/newdrugs/fda-approves-merck-s-liptruzet-ezetimibe-atorvastatin-new-product-can-help-lower-ldl-cholesterol-3776.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss Friday, May 3, 2013 - Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Liptruzet (ezetimibe and atorvastatin) tablets for the treatment of elevated low-density... Fri, 03 May 2013 20:05:01 GMT http://www.drugs.com/newdrugs/bristol-myers-squibb-receives-us-fda-snda-approval-sustiva-efavirenz-hiv-1-infected-pediatric-3775.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Sustiva (efavirenz), including dosing recommendations for... Fri, 03 May 2013 13:05:59 GMT http://www.drugs.com/newdrugs/fda-approves-plan-b-one-step-emergency-contraceptive-without-women-15-years-age-older-3773.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss April 30, 2013 -- The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription... Wed, 01 May 2013 00:04:09 GMT http://www.drugs.com/newdrugs/fda-approves-procysbi-nephropathic-cystinosis-3772.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss April 30, 2013 -- The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to... Tue, 30 Apr 2013 23:04:03 GMT http://www.drugs.com/newdrugs/fda-approves-actemra-children-polyarticular-juvenile-idiopathic-arthritis-3771.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss BASEL, April 30, 2013 -- Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Actemra (tocilizumab) for the treatment of polyarticular juvenile idiopathic arthritis (PJIA). The medicine can be used in children two... Tue, 30 Apr 2013 17:04:21 GMT http://www.drugs.com/newdrugs/fda-approves-kcentra-urgent-reversal-anticoagulation-adults-major-bleeding-3768.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss April 29, 2013 -- The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only... Mon, 29 Apr 2013 23:04:41 GMT http://www.drugs.com/newdrugs/fda-approves-amitiza-opioid-induced-constipation-3766.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss BETHESDA, Md. & DEERFIELD, Ill.--(BUSINESS WIRE)--Apr. 23, 2013-- Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A., Inc. announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Sucampo’s... Tue, 23 Apr 2013 19:04:00 GMT http://www.drugs.com/newdrugs/alcon-announces-fda-approval-simbrinza-suspension-new-beta-blocker-free-fixed-combination-therapy-3762.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss Basel, April 19, 2013 -- Alcon, the global leader in eye care and a division of Novartis, announces US FDA approval for Simbrinza Suspension, indicated for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle... Mon, 22 Apr 2013 13:04:53 GMT http://www.drugs.com/newdrugs/bioalliance-pharma-s-sitavig-receives-fda-approval-herpes-labialis-3758.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss Paris, April 15, 2013 – BioAlliance Pharma SA (Euronext Paris - BIO), today announced the receipt of marketing authorization from the U.S. Food and Drug Administration (FDA) for Sitavig in the treatment of recurring Herpes labialis, marking the... Mon, 15 Apr 2013 21:04:47 GMT http://www.drugs.com/newdrugs/taro-receives-fda-approval-topicort-desoximetasone-topical-0-25-3756.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss HAWTHORNE, N.Y.--April 12, 2013--Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration (“FDA”) for its New Drug Application (“NDA”) Topicort (desoximetasone) Topical... Mon, 15 Apr 2013 13:04:57 GMT http://www.drugs.com/newdrugs/fda-approves-diclegis-pregnant-women-experiencing-nausea-vomiting-3749.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss April 8, 2013 -- The U.S. Food and Drug Administration today approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting. Diclegis is a delayed-release tablet intended for women... Tue, 09 Apr 2013 22:04:39 GMT http://www.drugs.com/newdrugs/bausch-lomb-receives-fda-approval-prolensa-3742.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss MADISON, NJ - Bausch + Lomb, the global eye health company, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for Prolensa (bromfenac ophthalmic solution) 0.07 percent prescription... Mon, 08 Apr 2013 15:04:35 GMT http://www.drugs.com/newdrugs/fda-approves-tris-pharma-s-new-application-karbinal-er-3735.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss MONMOUTH JUNCTION, N.J., April 3, 2013 /PRNewswire/ -- Tris Pharma, a specialty pharmaceutical company focused on developing innovative drug delivery technologies, today announced that the U.S. Food and Drug Administration (FDA) has approved its New... Wed, 03 Apr 2013 22:04:19 GMT http://www.drugs.com/newdrugs/fda-approves-quartette-levonorgestrel-ethinyl-estradiol-ethinyl-estradiol-prevention-pregnancy-3733.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss JERUSALEM--(BUSINESS WIRE)--Mar. 29, 2013-- Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets for the... Sat, 30 Mar 2013 00:03:19 GMT http://www.drugs.com/newdrugs/fda-approves-invokana-type-2-diabetes-3732.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss March 29, 2013 -- The U.S. Food and Drug Administration today approved < a href="http://www.drugs.com/invokana.html">Invokana (canagliflozin) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes. Type 2... Fri, 29 Mar 2013 22:03:43 GMT http://www.drugs.com/newdrugs/fda-approves-tecfidera-new-multiple-sclerosis-3731.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss March 27, 2013 -- The U.S. Food and Drug Administration today approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS). MS is a chronic, inflammatory, autoimmune disease of the central... Wed, 27 Mar 2013 21:03:27 GMT http://www.drugs.com/newdrugs/fda-approves-aciphex-sprinkle-rabeprazole-sodium-children-ages-1-11-3759.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss Woodcliff Lake, NJ, March 26, 2013 - Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Aciphex Sprinkle Delayed-Release Capsules 5mg and 10mg for the treatment of Gastroesophageal Reflux Disease (GERD) in... Tue, 26 Mar 2013 22:03:25 GMT http://www.drugs.com/newdrugs/fda-approves-tobi-podhaler-type-bacterial-lung-infection-cystic-fibrosis-patients-3730.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss March 22, 2013 -- The U.S. Food and Drug Administration today approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections. Cystic... Sun, 24 Mar 2013 22:03:23 GMT http://www.drugs.com/newdrugs/fda-approves-dotarem-new-magnetic-resonance-imaging-agent-3728.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss March 20, 2013 -- The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older. Dotarem is a... Wed, 20 Mar 2013 22:03:03 GMT http://www.drugs.com/newdrugs/fda-approves-lymphoseek-help-locate-lymph-nodes-patients-certain-cancers-3724.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss March 13, 2013 -- The U.S. Food and Drug Administration today approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who... Wed, 13 Mar 2013 22:03:52 GMT http://www.drugs.com/newdrugs/fda-approves-once-monthly-abilify-maintena-aripiprazole-extended-release-injectable-suspension-3714.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss TOKYO & COPENHAGEN, Denmark--(BUSINESS WIRE)--Feb 28, 2013 - Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced the U.S. Food and Drug Administration (FDA) has approved Abilify Maintena (aripiprazole) for... Fri, 01 Mar 2013 13:03:01 GMT http://www.drugs.com/newdrugs/pernix-therapeutics-receives-fda-approval-vituz-3710.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss THE WOODLANDS, Texas--(BUSINESS WIRE)--Feb 28, 2013 - Pernix Therapeutics Holdings, Inc., a specialty pharmaceutical company, today announced that its subsidiary, Hawthorn Pharmaceuticals, Inc., has received U.S. Food and Drug Administration... Thu, 28 Feb 2013 14:02:49 GMT http://www.drugs.com/newdrugs/fda-approves-osphena-postmenopausal-women-experiencing-dyspareunia-3706.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss February 26, 2013 -- The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to... Tue, 26 Feb 2013 21:02:12 GMT http://www.drugs.com/newdrugs/fda-approves-stivarga-advanced-gastrointestinal-stromal-tumors-3702.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss February 25, 2013 -- The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to... Mon, 25 Feb 2013 23:02:46 GMT http://www.drugs.com/newdrugs/epiduo-gel-becomes-first-topical-acne-available-children-young-9-years-old-3701.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss FORT WORTH, Texas, Feb. 19, 2013 /PRNewswire/ -- Galderma Laboratories, L.P. today announced that the U.S. Food and Drug Administration (FDA) has approved Epiduo (adapalene 0.1%/BPO 2.5%) Gel to treat acne in children as young as 9 years old... Mon, 25 Feb 2013 19:02:01 GMT http://www.drugs.com/newdrugs/fda-approves-kadcyla-late-stage-breast-cancer-3697.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss February 22, 2013 -- The U.S. Food and Drug Administration today approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer. HER2 is a protein involved in normal cell growth.... Fri, 22 Feb 2013 18:02:15 GMT http://www.drugs.com/newdrugs/fda-approves-pomalyst-advanced-multiple-myeloma-3681.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss February 8, 2013 -- The U.S. Food and Drug Administration today approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. Multiple myeloma is a form of blood... Fri, 08 Feb 2013 21:02:13 GMT http://www.drugs.com/newdrugs/warner-chilcott-announces-fda-approval-new-ulcerative-colitis-product-delzicol-3680.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss DUBLIN, Ireland, Feb. 5, 2013 -- Warner Chilcott plc today announced that the United States Food and Drug Administration (FDA) has approved its new 400 mg mesalamine product indicated for the treatment of ulcerative colitis. The product will be... Wed, 06 Feb 2013 23:02:57 GMT http://www.drugs.com/newdrugs/fda-approves-ravicti-chronic-management-some-urea-cycle-disorders-3676.html?utm_source=ddc&utm_medium=rss&utm_campaign=rss February 1, 2013 -- The U.S. Food and Drug Administration today approved Ravicti (glycerol phenylbutyrate) for the chronic management of some urea cycle disorders (UCDs) in patients ages 2 years and older. UCDs are genetic disorders that involve... Fri, 01 Feb 2013 23:02:15 GMT