New Drug Approvals

Xofigo (radium Ra 223 dichloride) Injection

Company: Bayer HealthCare Pharmaceuticals Inc.
Date of Approval: May 15, 2013
Treatment for: Prostate Cancer

Xofigo (radium Ra 223 dichloride) is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer.

• FDA Approves Xofigo for Advanced Prostate Cancer - May 15, 2013

Breo Ellipta (fluticasone and vilanterol) Inhalation Powder

Company: GlaxoSmithKline plc (GSK) and Theravance, Inc.
Date of Approval: May 10, 2013
Treatment for: Chronic Obstructive Pulmonary Disease

Breo Ellipta (fluticasone and vilanterol) is a once-a-day inhaled corticosteroid/long-acting beta2 agonist (LABA) combination indicated for the treatment of patients with chronic obstructive pulmonary disease (COPD).

• FDA Approves Breo Ellipta to Treat Chronic Obstructive Pulmonary Disease (COPD) - May 10, 2013
• FDA Advisory Committee Recommends Approval of Breo Ellipta for the Treatment of COPD - April 17, 2013
• GSK and Theravance Announce FDA Acceptance of FF/VI New Drug Application (NDA) Submission in the US for COPD - September 26, 2012

Nymalize (nimodipine) Oral Solution

Company: Arbor Pharmaceuticals
Date of Approval: May 10, 2013
Treatment for: Subarachnoid Hemorrhage

Nymalize (nimodipine) is a calcium channel blocker indicated to improve neurological outcome following subarachnoid hemorrhage.

• Arbor Pharmaceuticals Announces FDA Approval of Nymalize - May 13, 2013

Liptruzet (atorvastatin and ezetimibe) Tablets

Company: Merck
Date of Approval: May 3, 2013
Treatment for: Heterozygous Familial Hypercholesterolemia

Liptruzet (atorvastatin and ezetimibe) is a statin (HMG-CoA reductase inhibitor) and cholesterol absorption inhibitor combination indicated for the treatment of hyperlipidemia.

• FDA Approves Merck’s Liptruzet (ezetimibe and atorvastatin), a New Product That Can Help Lower LDL Cholesterol - May 3, 2013
• Merck Announces FDA Acknowledgement of Resubmission of New Drug Application for Ezetimibe/Atorvastatin Tablets - January 3, 2013

Procysbi (cysteamine bitartrate) Delayed-Release Capsules - formerly RP103

Company: Raptor Pharmaceutical Corp.
Date of Approval: April 30, 2013
Treatment for: Nephropathic Cystinosis

Procysbi (cysteamine bitartrate) is a cystine depleting agent indicated for the treatment of nephropathic cystinosis.

• FDA Approves Procysbi for Nephropathic Cystinosis - April 30, 2013
• Raptor Pharmaceutical Corp. Provides Update on Procysbi NDA Review - December 27, 2012
• Raptor Pharmaceutical Announces FDA Acceptance of New Drug Application for RP103 for the Potential Treatment of Nephropathic Cystinosis - June 15, 2012
• Raptor Pharmaceutical Corp. Submits New Drug Application for RP103 for the Potential Treatment of Nephropathic Cystinosis - April 2, 2012

Kcentra (prothrombin complex concentrate, human)

Company: CSL Behring
Date of Approval: April 29, 2013
Treatment for: Reversal of Vitamin K Antagonist (VKA) Anticoagulation

• FDA Approves Kcentra for the Urgent Reversal of Anticoagulation in Adults with Major Bleeding - April 29, 2013

Simbrinza (brimonidine and brinzolamide) Ophthalmic Suspension

Company: Alcon
Date of Approval: April 19, 2013
Treatment for: Glaucoma

Simbrinza (brimonidine and brinzolamide) is a fixed combination of an alpha 2 adrenergic receptor agonist and a carbonic anhydrase inhibitor indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

• Alcon Announces FDA Approval of Simbrinza Suspension, a New Beta Blocker-Free, Fixed-Combination Therapy for Glaucoma Patients - April 22, 2013

Sitavig (acyclovir) Buccal Tablets

Company: BioAlliance Pharma SA
Date of Approval: April 12, 2013
Treatment for: Herpes Simplex Labialis

Sitavig (acyclovir) is a mucoadhesive buccal tablet formulation of the antiviral drug acyclovir indicated for the treatment of recurrent orofacial herpes (cold sores).

• BioAlliance Pharma's Sitavig Receives FDA Approval for the Treatment of Herpes Labialis - April 15, 2013
• BioAlliance Pharma SA : Receivability of Sitavig US Registration Dossier (NDA) for the Treatment of Recurrent Orofacial Herpes Validated by the FDA - June 1, 2012

Diclegis (doxylamine and pyridoxine) Delayed-Release Tablets

Company: Duchesnay Inc.
Date of Approval: April 8, 2013
Treatment for: Nausea and Vomiting of Pregnancy

Diclegis (doxylamine and pyridoxine) is an antihistamine and vitamin B6 analog combination indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

• FDA Approves Diclegis for Pregnant Women Experiencing Nausea and Vomiting - April 9, 2013

Prolensa (bromfenac) Ophthalmic Solution

Company: Bausch + Lomb
Date of Approval: April 5, 2013
Treatment for: Postoperative Ocular Inflammation

Prolensa (bromfenac ophthalmic solution) is a topical nonsteroidal anti-inflammatory indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

• Bausch + Lomb Receives FDA Approval for Prolensa - April 8, 2013

Invokana (canagliflozin) Tablets

Company: Janssen Research & Development, LLC
Date of Approval: March 29, 2013
Treatment for: Diabetes Type 2

Invokana (canagliflozin) is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.

• FDA Approves Invokana to Treat Type 2 Diabetes - March 29, 2013
• FDA Advisory Committee Recommends Approval of Canagliflozin for Treatment of Adults with Type 2 Diabetes - January 11, 2013
• Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin to Treat Patients with Type 2 Diabetes - May 31, 2012

Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets

Company: Teva Branded Pharmaceutical Products R&D, Inc.
Date of Approval: March 28, 2013
Treatment for: Contraception

Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) is a 91-day extended regimen oral contraceptive indicated for the prevention of pregnancy.

• FDA Approves Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets for the Prevention of Pregnancy - March 29, 2013

Karbinal ER (carbinoxamine) Extended-Release Oral Suspension

Company: Tris Pharma, Inc.
Date of Approval: March 28, 2013
Treatment for: Allergic Conjunctivitis, Allergic Reaction, Allergic Rhinitis, Allergic Urticaria

Karbinal ER (carbinoxamine maleate) extended-release oral suspension is an H1 receptor antagonist indicated for the symptomatic treatment of seasonal and perennial allergic rhinitis.

• FDA Approves Tris Pharma's New Drug Application for Karbinal ER - April 3, 2013

Tecfidera (dimethyl fumarate) Delayed-Release Capsules - formerly BG-12

Company: Biogen Idec
Date of Approval: March 27, 2013
Treatment for: Multiple Sclerosis

Tecfidera (dimethyl fumarate) is an oral Nrf2 pathway activator for the treatment of relapsing forms of multiple sclerosis.

• FDA Approves Tecfidera - a New Treatment for Multiple Sclerosis - March 27, 2013
• Biogen Idec Receives Notification of PDUFA Date Extension - October 18, 2012
• US and EU Regulatory Authorities Accept Oral BG-12 Marketing Applications for Review - May 9, 2012
• Biogen Idec Submits Application to FDA for Approval of Oral BG-12 to Treat Multiple Sclerosis - February 28, 2012

TOBI Podhaler (tobramycin) Inhalation Powder

Company: Novartis Pharmaceuticals Corporation
Date of Approval: March 22, 2013
Treatment for: Cystic Fibrosis

TOBI Podhaler (tobramycin inhalation powder) is an antibacterial aminoglycoside indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.

• FDA Approves TOBI Podhaler to Treat a Type of Bacterial Lung Infection in Cystic Fibrosis Patients - March 24, 2013

Dotarem (gadoterate meglumine) Injection

Company: Guerbet
Date of Approval: March 20, 2013
Treatment for: Diagnostic

Dotarem (gadoterate meglumine) is a gadolinium-based contrast agent indicated for use in magnetic resonance imaging (MRI).

• FDA Approves Dotarem, a New Magnetic Resonance Imaging Agent - March 20, 2013
• Medical Imaging Drugs Advisory Committee Recommends Approval of Guerbet NDA for Dotarem (gadoterate meglumine) - February 15, 2013

Lymphoseek (technetium Tc 99m tilmanocept) Injection

Company: Navidea Biopharmaceuticals
Date of Approval: March 13, 2013
Treatment for: Diagnostic

Lymphoseek (technetium Tc 99m tilmanocept) Injection is a radioactive diagnostic agent indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma.

• FDA Approves Lymphoseek to Help Locate Lymph Nodes in Patients with Certain Cancers - March 13, 2013
• Navidea Biopharmaceuticals Announces PDUFA Goal Date for Lymphoseek New Drug Application Resubmission - November 13, 2012
• Navidea Biopharmaceuticals Resubmits New Drug Application for Lymphoseek to FDA - November 2, 2012
• Navidea Biopharmaceuticals Receives Complete Response Letter from FDA for Lymphoseek NDA Due to Manufacturing Deficiencies - September 19, 2012

Osphena (ospemifene) Tablets

Company: Shionogi Inc.
Date of Approval: February 26, 2013
Treatment for: Dyspareunia

Osphena (ospemifene) is an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause.

• FDA Approves Osphena for Postmenopausal Women Experiencing Dyspareunia - February 26, 2013
• Shionogi Files a New Drug Application for Ospemifene Oral Tablets 60mg for the Treatment of Vulvar and Vaginal Atrophy - May 9, 2012

Kadcyla (ado-trastuzumab emtansine) Injection

Company: Genentech, Inc.
Date of Approval: February 22, 2013
Treatment for: Breast Cancer

Kadcyla (ado-trastuzumab emtansine) is a HER2-targeted antibody and microtubule inhibitor conjugate indicated for the treatment of patients with HER2-positive, metastatic breast cancer.

• FDA Approves Kadcyla for Late-Stage Breast Cancer - February 22, 2013

Vituz (chlorpheniramine and hydrocodone) Oral Solution

Company: Hawthorn Pharmaceuticals, Inc.
Date of Approval: February 20, 2013
Treatment for: Cough, Cold Symptoms

Vituz (chlorpheniramine and hydrocodone) Oral Solution is an antihistamine/antitussive combination indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold.

• Pernix Therapeutics Receives FDA Approval for Vituz - February 28, 2013