New Drug Approvals Archive for 2010

Actemra (tocilizumab) Injection

Date of Approval: January 8, 2010
Company: Genentech USA, Inc.
Treatment for: Rheumatoid Arthritis, Giant Cell Arteritis, Systemic Sclerosis-Associated Interstitial Lung Disease, Juvenile Idiopathic Arthritis, Cytokine Release Syndrome, COVID-19

Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment of rheumatoid arthritis, giant cell arteritis, systemic sclerosis-associated interstitial lung disease, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, cytokine release syndrome, and COVID-19.

• FDA Approves Actemra for the Treatment of Moderately to Severely Active Rheumatoid Arthritis
• Actemra (tocilizumab) FDA Approval History

Ampyra (dalfampridine) Extended Release Tablets - formerly Fampridine-SR

Date of Approval: January 22, 2010
Company: Acorda Therapeutics, Inc.
Treatment for: Multiple Sclerosis

Ampyra (dalfampridine) is an oral potassium channel blocker indicated to improve walking ability in people with multiple sclerosis.

• FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis
• Ampyra (dalfampridine) FDA Approval History

Victoza (liraglutide) Injection

Date of Approval: January 25, 2010
Company: Novo Nordisk A/S
Treatment for: Type 2 Diabetes

Victoza (liraglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in patients 10 years and older with type 2 diabetes mellitus, and to reduce the risk of heart attack, stroke and cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.

• FDA Approves Novo-Nordisk's Diabetes Drug Victoza
• Victoza (liraglutide) FDA Approval History

Oleptro (trazodone) Extended Release Tablets

Date of Approval: February 2, 2010
Company: Labopharm Inc.
Treatment for: Depression

Marketing Status: Discontinued

Oleptro (trazodone) is a once-daily serotonin antagonist reuptake inhibitor (SARI) formulation for the treatment of major depressive disorder (MDD) in adults.

• Labopharm Receives FDA Approval for Oleptro
• Oleptro (trazodone) FDA Approval History

Xiaflex (collagenase clostridium histolyticum)

Date of Approval: February 3, 2010
Company: BioSpecifics Technologies Corp.
Treatment for: Dupuytren's Contracture

Xiaflex (collagenase clostridium histolyticum) is a collagenase product for the treatment of Dupuytren's contracture, a condition that affects the connective tissue that lies beneath the skin in the palm.

• Auxilium Announces U.S. Food and Drug Administration Approval for Xiaflex for the Treatment of Dupuytren's Contracture
• Xiaflex (collagenase clostridium histolyticum) FDA Approval History

Menveo (meningococcal conjugate vaccine)

Date of Approval: February 19, 2010
Company: GlaxoSmithKline
Treatment for: Meningococcal Disease Prophylaxis

Menveo (Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135.

• Novartis Gets US Approval for Menveo Meningitis Vaccine
• Menveo (meningococcal conjugate vaccine) FDA Approval History

Cayston (aztreonam lysine) Inhalation Solution

Date of Approval: February 22, 2010
Company: Gilead Sciences, Inc.
Treatment for: Pneumonia with Cystic Fibrosis

Cayston (aztreonam lysine for inhalation) is an inhaled anti-pseudomonal therapy for people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa infection.

• U.S. Food and Drug Administration Approves Cayston (Aztreonam for Inhalation Solution) for the Improvement of Respiratory Symptoms in Cystic Fibrosis Patients with Pseudomonas Aeruginosa
• Cayston (aztreonam lysine) FDA Approval History

Prevnar 13 (pneumococcal 13-valent conjugate vaccine)

Date of Approval: February 24, 2010
Company: Pfizer Inc.
Treatment for: Pneumococcal Disease Prophylaxis

Prevnar 13 (pneumococcal 13-valent conjugate vaccine) is a vaccine indicated for active immunization against invasive pneumococcal disease.

• FDA Approves Prevnar 13 Pneumococcal Disease Vaccine
• Prevnar 13 (pneumococcal 13-valent conjugate vaccine) FDA Approval History

VPRIV (velaglucerase alfa) for Injection

Date of Approval: February 26, 2010
Company: Shire plc
Treatment for: Gaucher Disease

VPRIV (velaglucerase alfa) is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy for pediatric and adult patients with Type 1 Gaucher disease.

• FDA Approves VPRIV to Treat Gaucher Disease
• VPRIV (velaglucerase alfa) FDA Approval History

Exalgo (hydromorphone) Extended Release Tablets

Date of Approval: March 1, 2010
Company: Covidien
Treatment for: Pain in Opioid Tolerant Patients

Marketing Status: Discontinued

Exalgo (hydromorphone) is a once-a-day extended release opioid formulation for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.

• FDA Approves Exaglo (hydromorphone HCl) Extended-Release Tablets
• Exalgo (hydromorphone) FDA Approval History

Hizentra (immune globulin subcutaneous (human)) Liquid

Date of Approval: March 4, 2010
Company: CSL Behring
Treatment for: Primary Immunodeficiency Syndrome, Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Hizentra (immune globulin subcutaneous (human)) is an immune globulin indicated for the treatment of primary immunodeficiency, and for the maintenance treatment of chronic inflammatory demyelinating polyneuropathy.

• CSL Behring Receives FDA Approval of Hizentra, First 20 Percent Subcutaneous Immunoglobulin Therapy
• Hizentra (immune globulin subcutaneous (human)) FDA Approval History

Silenor (doxepin) Tablets

Date of Approval: March 17, 2010
Company: Somaxon Pharmaceuticals, Inc.
Treatment for: Insomnia

Silenor (doxepin) is a low-dose oral tablet formulation of the H1 receptor antagonist doxepin indicated for the treatment of insomnia characterized by difficulties with sleep maintenance.

• Somaxon Announces FDA Approval of Silenor (doxepin) for the Treatment of Insomnia
• Silenor (doxepin) FDA Approval History

Carbaglu (carglumic acid) Tablets

Date of Approval: March 18, 2010
Company: Orphan Europe
Treatment for: NAGS Deficiency Hyperammonemia

Carbaglu (carglumic acid) is a carbamoyl phosphate synthetase 1 (CPS 1) activator indicated for the treatment of hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS).

• FDA Approves Carbaglu to Treat Condition That Causes Elevated Ammonia Levels
• Carbaglu (carglumic acid) FDA Approval History

Zyclara (imiquimod) Cream

Date of Approval: March 25, 2010
Company: Graceway Pharmaceuticals, LLC
Treatment for: Keratosis, Condylomata Acuminata

Zyclara (imiquimod) is an immune response modifier indicated for the topical treatment of actinic keratoses and external genital warts.

• FDA Approves Zyclara (imiquimod) Cream, 3.75% for the Treatment of Actinic Keratoses
• Zyclara (imiquimod) FDA Approval History

Asclera (polidocanol) Injection

Date of Approval: March 30, 2010
Company: Chemische Fabrik Kreussler & Co.
Treatment for: Varicose Veins

Asclera (polidocanol) is a sclerosing agent used for the treatment of varicose veins.

• FDA Approves Asclera to Treat Small Varicose Veins
• Asclera (polidocanol) FDA Approval History

Pancreaze (pancrelipase) Delayed-Release Capsules

Date of Approval: April 12, 2010
Company: Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Treatment for: Pancreatic Exocrine Dysfunction

Pancreaze (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

• FDA Approves Pancreatic Enzyme Product, Pancreaze
• Pancreaze (pancrelipase) FDA Approval History

Oravig (miconazole) Buccal Tablets - formerly Loramyc

Date of Approval: April 16, 2010
Company: BioAlliance Pharma SA
Treatment for: Oral Thrush

Oravig (miconazole) is a mucoadhesive buccal azole antifungal therapy indicated for the local treatment of oropharyngeal candidiasis in adults.

• FDA Approves Oravig (miconazole) Buccal Tablets for Treatment of Oropharyngeal Candidiasis
• Oravig (miconazole) FDA Approval History

Zortress (everolimus) Tablets - formerly Certican

Date of Approval: April 22, 2010
Company: Novartis Pharma AG
Treatment for: Organ Transplant, Rejection Prophylaxis

Zortress (everolimus) is an oral inhibitor of the mTOR pathway indicated for the prevention of rejection of kidney transplants in adult patients at low-to-moderate immunologic risk.

• Novartis Receives US FDA Approval for Zortress (everolimus) to Prevent Organ Rejection in Adult Kidney Transplant Recipients
• Zortress (everolimus) FDA Approval History

Provenge (sipuleucel-T) Suspension for Intravenous Infusion - formerly APC8015

Date of Approval: April 29, 2010
Company: Dendreon Corporation
Treatment for: Prostate Cancer

Provenge (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

• FDA Approves Provenge - a Cellular Immunotherapy for Men With Advanced Prostate Cancer
• Provenge (sipuleucel-T) FDA Approval History

Vimovo (naproxen and esomeprazole magnesium) - formerly PN 400

Date of Approval: April 30, 2010
Company: Horizon Therapeutics USA, Inc.
Treatment for: Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, NSAID-Induced Ulcer Prophylaxis

Vimovo is a combination of the pain reliever naproxen (NSAID) and esomeprazole magnesium (proton pump inhibitor) indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.

• FDA Approved Vimovo for Arthritis Patients At Risk of Developing NSAID-Associated Gastric Ulcers
• Vimovo (naproxen and esomeprazole magnesium) FDA Approval History

Natazia (dienogest and estradiol valerate) - formerly Qlaira

Date of Approval: May 6, 2010
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Contraception, Heavy Menstrual Bleeding

Natazia (dienogest and estradiol valerate) is a combination oral contraceptive indicated for use by women to prevent pregnancy and to treat heavy menstrual bleeding.

• FDA Approves Natazia - New Combination Product Oral Contraceptive
• Natazia (dienogest and estradiol valerate) FDA Approval History

Sprix (ketorolac tromethamine) Nasal Spray - formerly ROX-888

Date of Approval: May 14, 2010
Company: Egalet Corporation
Treatment for: Pain

Sprix (ketorolac tromethamine) is an intranasal analgesic for the management of acute moderate to severe pain.

• Roxro Announces FDA Approval of Sprix
• Sprix (ketorolac tromethamine) FDA Approval History

Zymaxid (gatifloxacin) Ophthalmic Solution

Date of Approval: May 18, 2010
Company: AbbVie Inc.
Treatment for: Conjunctivitis, Bacterial

Zymaxid (gatifloxacin ophthalmic) is a fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.

• Allergan Receives FDA Approval for Zymaxid Ophthalmic Solution
• Zymaxid (gatifloxacin) FDA Approval History

Lumizyme (alglucosidase alfa)

Date of Approval: May 24, 2010
Company: Genzyme Corporation
Treatment for: Pompe Disease

Lumizyme (alglucosidase alfa) is a lysosomal glycogen-specific enzyme indicated for patients with Pompe disease.

• FDA Approves Lumizyme for Late-Onset Pompe Disease
• Lumizyme (alglucosidase alfa) FDA Approval History

Prolia (denosumab) Injection

Date of Approval: June 1, 2010
Company: Amgen Inc.
Treatment for: Osteoporosis

Prolia is a RANK ligand (RANKL) inhibitor indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, for the treatment of bone loss in patients with prostate or breast cancer undergoing hormone ablation therapy, as a treatment to increase bone mass in men with osteoporosis at high risk for fracture, and for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture.

• FDA Approves Amgen's Prolia (Denosumab) for Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture
• Prolia (denosumab) FDA Approval History

Cysview (hexaminolevulinate) for Intravesical Solution - formerly Hexvix

Date of Approval: May 28, 2010
Company: Photocure ASA
Treatment for: Diagnosis and Investigation

Cysview (hexaminolevulinate HCl) is an optical imaging agent indicated for use in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder.

• Cysview (Hexaminolevulinate HCl) Approved by the FDA for Cystoscopic Detection of Papillary Bladder Cancer
• Cysview (hexaminolevulinate) FDA Approval History

Jalyn (dutasteride and tamsulosin) Capsules

Date of Approval: June 14, 2010
Company: GlaxoSmithKline
Treatment for: Benign Prostatic Hyperplasia

Jalyn is a combination of dutasteride (5α-reductase inhibitor) and tamsulosin (alpha-adrenergic antagonist) indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

• FDA approves Jalyn, a fixed-dose combination of dutasteride and tamsulosin, for symptomatic BPH in men with an enlarged prostate
• Jalyn (dutasteride and tamsulosin) FDA Approval History

Jevtana (cabazitaxel) Injection

Date of Approval: June 17, 2010
Company: Sanofi-aventis
Treatment for: Prostate Cancer

Jevtana (cabazitaxel) is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with hormone-refractory metastatic prostate cancer.

• Jevtana (cabazitaxel) Injection Approved by U.S. FDA After Priority Review
• Jevtana (cabazitaxel) FDA Approval History

Staxyn (vardenafil) Orally Disintegrating Tablets

Date of Approval: June 17, 2010
Company: GlaxoSmithKline and Merck & Co., Inc.
Treatment for: Erectile Dysfunction

Staxyn (vardenafil) is a phosphodiesterase type 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.

• FDA approves Staxyn (vardenafil HCl) orally disintegrating tablets for erectile dysfunction (ED)
• Staxyn (vardenafil) FDA Approval History

Dulera (mometasone furoate and formoterol fumarate) Inhaler

Date of Approval: June 22, 2010
Company: Organon Pharmaceuticals
Treatment for: Asthma

Dulera (mometasone furoate and formoterol fumarate) is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for the treatment of asthma in patients 5 years of age and older.

• FDA Approves Merck's Dulera (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol for the Treatment of Asthma in Patients 12 Years of Age and Older
• Dulera (mometasone furoate and formoterol fumarate) FDA Approval History

Butrans (buprenorphine) Transdermal System

Date of Approval: June 30, 2010
Company: Purdue Pharma L.P.
Treatment for: Pain

Butrans (buprenorphine) is a transdermal opioid analgesic for the management of moderate to severe chronic pain in patients requiring continuous treatment for an extended period of time.

• Purdue Pharma L.P. Receives FDA Approval for Butrans (buprenorphine) Transdermal System CIII
• Butrans (buprenorphine) FDA Approval History

Zuplenz (ondansetron) Oral Soluble Film

Date of Approval: July 2, 2010
Company: Aquestive Therapeutics
Treatment for: Nausea/Vomiting, Chemotherapy Induced, Nausea/Vomiting, Postoperative, Nausea/Vomiting, Radiation Induced

Zuplenz (ondansetron) is an oral soluble film formulation of the approved 5-HT3 receptor antagonist ondansetron for the prevention of nausea and vomiting associated with chemotherapy, nausea and vomiting associated with radiotherapy, and postoperative nausea and/or vomiting.

• FDA Approves Strativa Pharmaceuticals' Zuplenz (ondansetron) Oral Soluble Film
• Zuplenz (ondansetron) FDA Approval History

Glassia (alpha1-proteinase inhibitor (human)) Injection - formerly AAT-IV

Date of Approval: July 1, 2010
Company: Kamada Ltd.
Treatment for: Alpha-1 Proteinase Inhibitor Deficiency

Glassia is an alpha1-proteinase inhibitor that is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1antitrypsin deficiency.

• Kamada Wins FDA Approval for Glassia - a New Liquid, Ready-to-Use Treatment for Alpha-1 Antitrypsin Deficiency
• Glassia (alpha1-proteinase inhibitor (human)) FDA Approval History

Alsuma (sumatriptan) Injection

Date of Approval: June 29, 2010
Company: King Pharmaceuticals, Inc.
Treatment for: Migraine, Cluster Headaches

Marketing Status: Discontinued

Alsuma (sumatriptan injection) is a triptan indicated for the acute treatment of migraine attacks and cluster headache episodes.

• FDA Approves Alsuma Auto-Injector
• Alsuma (sumatriptan) FDA Approval History

Veltin (clindamycin and tretinoin) Gel - formerly Velac

Date of Approval: July 16, 2010
Company: Stiefel Laboratories, Inc.
Treatment for: Acne

Veltin Gel (clindamycin phosphate and tretinoin) is a combination of an antibiotic and a retinoid indicated for the topical treatment of acne vulgaris.

• Stiefel, a GSK company, Receives FDA Approval of Veltin (clindamycin phosphate and tretinoin) Gel 1.2%/0.025%
• Veltin (clindamycin and tretinoin) FDA Approval History

Tribenzor (amlodipine, hydrochlorothiazide and olmesartan) Tablets

Date of Approval: July 23, 2010
Company: Cosette Pharmaceuticals, Inc.
Treatment for: High Blood Pressure

Tribenzor (amlodipine, hydrochlorothiazide and olmesartan) is a three-in-one combination product taken once-daily for the treatment of hypertension.

• FDA Approves Tribenzor, A New Three-In-One Combination Product for the Treatment of High Blood Pressure
• Tribenzor (amlodipine, hydrochlorothiazide and olmesartan) FDA Approval History

Lastacaft (alcaftadine) Ophthalmic Solution

Date of Approval: July 28, 2010
Company: Allergan, Inc.
Treatment for: Conjunctivitis, Allergic

Lastacaft (alcaftadine ophthalmic solution) is a topical H1 histamine receptor antagonist for eye allergy itch relief.

• FDA Approves Lastacaft (alcaftadine ophthalmic solution) for Prevention of Itching Associated with Allergic Conjunctivitis
• Lastacaft (alcaftadine) FDA Approval History

Cuvposa (glycopyrrolate) Oral Solution

Date of Approval: July 28, 2010
Company: Shionogi Pharma Inc.
Treatment for: Chronic Drooling in Children

Cuvposa (glycopyrrolate) oral solution is an anticholinergic for the treatment of chronic severe drooling caused by neurologic disorders in children.

• FDA Approves Cuvposa for Chronic Drooling in Children
• Cuvposa (glycopyrrolate) FDA Approval History

Xeomin (incobotulinumtoxinA) Injection

Date of Approval: July 30, 2010
Company: Merz Pharmaceuticals, LLC
Treatment for: Cervical Dystonia, Blepharospasm, Facial Wrinkles, Upper Limb Spasticity, Excessive Salivation

Xeomin (incobotulinumtoxinA) is a botulinum toxin type A neurotoxin used for the treatment of chronic sialorrhea, upper limb spasticity, cervical dystonia, blepharospasm, and upper facial lines.

• FDA Approves Merz Pharmaceuticals' Xeomin (incobotulinumtoxinA) for the Treatment of Cervical Dystonia and Blepharospasm
• Xeomin (incobotulinumtoxinA) FDA Approval History

Suprep (sodium sulfate, potassium sulfate, magnesium sulfate) Oral Solution

Date of Approval: August 5, 2010
Company: Braintree Laboratories, Inc.
Treatment for: Bowel Preparation

Suprep (sodium sulfate, potassium sulfate, magnesium sulfate) is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.

• FDA Approves Suprep Bowel Prep Kit
• Suprep (sodium sulfate, potassium sulfate, magnesium sulfate) FDA Approval History

ella (ulipristal acetate)

Date of Approval: August 13, 2010
Company: HRA Pharma
Treatment for: Emergency Contraception

ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure.

• FDA Approves ella Tablets for Prescription Emergency Contraception
• ella (ulipristal acetate) FDA Approval History

Tekamlo (aliskiren and amlodipine) Tablets

Date of Approval: August 26, 2010
Company: Novartis Pharmaceuticals Corporation
Treatment for: High Blood Pressure

Marketing Status: Discontinued

Tekamlo (aliskiren and amlodipine) is a direct renin inhibitor and calcium channel blocker combination indicated for the treatment of high blood pressure.

• Novartis receives FDA approval of Tekamlo, a single-pill combination of aliskiren and amlodipine to treat high blood pressure
• Tekamlo (aliskiren and amlodipine) FDA Approval History

Krystexxa (pegloticase) Injection

Date of Approval: September 14, 2010
Company: Savient Pharmaceuticals, Inc.
Treatment for: Gout

Krystexxa (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.

• FDA Approves Krystexxa (pegloticase) for Gout
• Krystexxa (pegloticase) FDA Approval History

Gilenya (fingolimod) Capsules - formerly FTY720

Date of Approval: September 21, 2010
Company: Novartis
Treatment for: Multiple Sclerosis

Gilenya (fingolimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis.

• Novartis Gains FDA Approval For Gilenya, A Novel First-Line Multiple Sclerosis Treatment Shown To Significantly Reduce Relapses And Delay Disability Progression
• Gilenya (fingolimod) FDA Approval History

Beyaz (drospirenone, ethinyl estradiol and levomefolate calcium) Tablets

Date of Approval: September 24, 2010
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Birth Control, Premenstrual Dysphoric Disorder, Acne

Beyaz (drospirenone, ethinyl estradiol and levomefolate calcium) is an estrogen/progestin combined oral contraceptive containing a folate, indicated for use by women to prevent pregnancy, treat symptoms of premenstrual dysphoric disorder, treat moderate acne and to raise folate levels in women who choose to use an oral contraceptive for contraception.

• FDA Approves Beyaz - Combination Contraceptive Containing a Folate
• Beyaz (drospirenone, ethinyl estradiol and levomefolate calcium) FDA Approval History

Kapvay (clonidine hydrochloride) Extended-Release Tablets

Date of Approval: September 28, 2010
Company: Shionogi Inc.
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Kapvay (clonidine hydrochloride) is a centrally acting alpha2-adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications.

• Shionogi Announces FDA Approval of Kapvay - The First and Only Therapy Approved for Use with Stimulant Medication for the Treatment of ADHD
• Kapvay (clonidine hydrochloride) FDA Approval History

Aridol (mannitol) Inhalation Powder

Date of Approval: October 5, 2010
Company: Pharmaxis Ltd.
Treatment for: Bronchial Challenge Test

Aridol (mannitol inhalation powder) is a bronchial challenge test designed to help in the correct diagnosis and assessment of asthma.

• United States Food and Drug Administration Approves Aridol
• Aridol (mannitol) FDA Approval History

Atelvia (risedronate sodium) Delayed-Release Tablets

Date of Approval: October 8, 2010
Company: AbbVie Inc.
Treatment for: Osteoporosis

Atelvia (risedronate sodium) is a bisphosphonate in a delayed-release formulation for treatment of postmenopausal osteoporosis.

• Warner Chilcott Announces FDA Approval of Atelvia - Next Generation Actonel
• Atelvia (risedronate sodium) FDA Approval History

Sorilux (calcipotriene) Foam

Date of Approval: October 7, 2010
Company: Mayne Pharma
Treatment for: Psoriasis

Sorilux (calcipotriene) is a vitamin D analog indicated for the topical treatment of plaque psoriasis in patients 12 years and older.

• Stiefel, a GSK company, Receives FDA Approval of Sorilux (calcipotriene) Foam, 0.005%
• Sorilux (calcipotriene) FDA Approval History

Gamunex-C (immune globulin intravenous and subcutaneous) Injection

Date of Approval: October 13, 2010
Company: Talecris Biotherapeutics, Inc.
Treatment for: Primary Immunodeficiency Syndrome

Gamunex-C (immune globulin intravenous and subcutaneous) is indicated for the treatment of primary immunodeficiency (PI).

• Talecris Biotherapeutics Receives FDA Approval for Gamunex-C
• Gamunex-C (immune globulin intravenous and subcutaneous) FDA Approval History

Pradaxa (dabigatran etexilate) Capsules and Oral Pellets

Date of Approval: October 19, 2010
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism, Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery, Venous Thromboembolism

• to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation
• for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days
• to reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated
• for the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery
• for the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days
• to reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated.

• for the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days
• to reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated.

• FDA Approves Pradaxa to Prevent Stroke in People With Atrial Fibrillation
• Pradaxa (dabigatran etexilate) FDA Approval History

Bromday (bromfenac) Ophthalmic Solution - formerly XiDay

Date of Approval: October 16, 2010
Company: ISTA Pharmaceuticals, Inc.
Treatment for: Postoperative Ocular Inflammation

Marketing Status: Discontinued

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

• ISTA Pharmaceuticals Receives FDA Approval for Bromday
• Bromday (bromfenac) FDA Approval History

Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate) Tablets

Date of Approval: October 21, 2010
Company: AbbVie Inc.
Treatment for: Birth Control

Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate) is an estrogen/progestin COC indicated for use by women to prevent pregnancy.

• Warner Chilcott Announces FDA Approval of New Oral Contraceptive Lo Loestrin Fe
• Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate) FDA Approval History

Latuda (lurasidone) Tablets

Date of Approval: October 28, 2010
Company: Dainippon Sumitomo Pharma America, Inc.
Treatment for: Schizophrenia, Bipolar Disorder

Latuda (lurasidone) is an atypical antipsychotic agent for the treatment of schizophrenia and bipolar depression.

• FDA approves Latuda to treat schizophrenia in adults
• Latuda (lurasidone) FDA Approval History

Nuedexta (dextromethorphan and quinidine) - formerly Zenvia

Date of Approval: October 29, 2010
Company: Avanir Pharmaceuticals
Treatment for: Pseudobulbar Affect

Nuedexta (dextromethorphan and quinidine) is a first-in-class dual action glutamate inhibitor indicated for the treatment of pseudobulbar affect.

• Avanir Pharmaceuticals Announces FDA Approval of Nuedexta
• Nuedexta (dextromethorphan and quinidine) FDA Approval History

Teflaro (ceftaroline fosamil) Injection

Date of Approval: October 29, 2010
Company: AbbVie Inc.
Treatment for: Pneumonia, Skin and Structure Infection

Teflaro (ceftaroline fosamil) is a cephalosporin antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

• FDA Approves Teflaro for Bacterial Infections
• Teflaro (ceftaroline fosamil) FDA Approval History

Ofirmev (acetaminophen) Intravenous Injection - formerly Acetavance

Date of Approval: November 2, 2010
Company: Cadence Pharmaceuticals, Inc.
Treatment for: Pain, Fever

Ofirmev (acetaminophen) is an intravenous analgesic product for the treatment of acute pain and fever in adults and children.

• Cadence Pharmaceuticals Announces FDA Approval of Ofirmev (acetaminophen) injection for the Management of Pain and Fever
• Ofirmev (acetaminophen) FDA Approval History

Kombiglyze XR (saxagliptin and metformin) Extended-Release Tablets

Date of Approval: November 5, 2010
Company: AstraZeneca
Treatment for: Type 2 Diabetes

Kombiglyze XR (saxagliptin and metformin) is a once-daily fixed dose combination of the dipeptidyl peptidase-4 (DPP-4) inhibitor Onglyza (saxagliptin) and extended release metformin for the treatment of type 2 diabetes.

• Kombiglyze XR (Saxagliptin and Metformin HCl Extended-Release) Tablets Approved in the U.S. for the Treatment of Type 2 Diabetes Mellitus in Adults
• Kombiglyze XR (saxagliptin and metformin) FDA Approval History

Egrifta WR (tesamorelin) Injection - formerly Egrifta

Date of Approval: November 10, 2010
Company: Theratechnologies
Treatment for: Reduction of Excess Abdominal Fat in HIV-Infected Patients with Lipodystrophy

Egrifta WR (tesamorelin) is a synthetic analogue of growth hormone releasing factor (GRF) for the treatment of excess abdominal fat in HIV patients with lipodystrophy.

• FDA Approves Egrifta (tesamorelin for injection): First and Only Treatment for the Reduction of Excess Abdominal Fat in HIV-infected Patients with Lipodystrophy
• Egrifta WR (tesamorelin) FDA Approval History

Halaven (eribulin mesylate) Injection

Date of Approval: November 15, 2010
Company: Eisai Co., Ltd.

Halaven (eribulin mesylate) is a microtubule inhibitor indicated for the treatment of patients with metastatic breast cancer, and liposarcoma.

• FDA Approves Halaven for Late-Stage Breast Cancer
• Halaven (eribulin mesylate) FDA Approval History

Xgeva (denosumab) Injection

Date of Approval: November 18, 2010
Company: Amgen Inc.
Treatment for: Osteolytic Bone Metastases of Solid Tumors, Osteolytic Bone Lesions of Multiple Myeloma, Giant Cell Tumor of Bone, Hypercalcemia of Malignancy

Xgeva (denosumab) is a RANK ligand (RANKL) inhibitor indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. Xgeva is also indicated for treatment giant cell tumor of bone and for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

• FDA Approves Amgen's Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Bone Metastases from Solid Tumors
• Xgeva (denosumab) FDA Approval History

Moxeza (moxifloxacin) Ophthalmic Solution

Date of Approval: November 19, 2010
Company: Alcon, Inc.
Treatment for: Conjunctivitis, Bacterial

Moxeza (moxifloxacin hydrochloride ophthalmic solution) is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.

• FDA Approves Moxeza for Bacterial Conjunctivitis
• Moxeza (moxifloxacin) FDA Approval History

Gablofen (baclofen) Injection

Date of Approval: November 19, 2010
Company: CNS Therapeutics
Treatment for: Cerebral Spasticity, Chronic Spasticity

Gablofen (baclofen) is a gamma-aminobutyric acid (GABA) ergic agonist indicated for use in the management of severe spasticity.

• FDA Approves Movement Disorder Drug from CNS Therapeutics: Gablofen (Baclofen Injection) for the Treatment of Severe Spasticity
• Gablofen (baclofen) FDA Approval History

Axiron (testosterone) Topical Solution

Date of Approval: November 23, 2010
Company: Eli Lilly and Company
Treatment for: Hypogonadism, Male

Marketing Status: Discontinued

Axiron (testosterone) is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

• Lilly and Acrux Receive FDA Approval for Axiron (Testosterone) Topical Solution CIII
• Axiron (testosterone) FDA Approval History

Safyral (drospirenone, ethinyl estradiol and levomefolate calcium) Tablets

Date of Approval: December 16, 2010
Company: Bayer HealthCare Pharmaceuticals, Inc.
Treatment for: Birth Control

Safyral (drospirenone, ethinyl estradiol and levomefolate calcium) is an estrogen/progestin combined oral contraceptive containing a folate, indicated for use by women to prevent pregnancy, and to raise folate levels in women who choose to use an oral contraceptive for contraception.

• FDA Approves Safyral - Oral Contraceptive That Also Raises Folate Levels
• Safyral (drospirenone, ethinyl estradiol and levomefolate calcium) FDA Approval History

Amturnide (aliskiren, amlodipine and hydrochlorothiazide) Tablets

Date of Approval: December 21, 2010
Company: Novartis Pharmaceuticals Corporation
Treatment for: High Blood Pressure

Marketing Status: Discontinued

Amturnide (aliskiren, amlodipine and hydrochlorothiazide) is a direct renin inhibitor, calcium channel blocker and diuretic combination for the treatment of high blood pressure.

• Novartis Gains FDA Approval for Amturnide, a Triple-Combination Pill to Treat High Blood Pressure in Patients Uncontrolled on Two Medications
• Amturnide (aliskiren, amlodipine and hydrochlorothiazide) FDA Approval History

Fortesta (testosterone) Gel

Date of Approval: December 29, 2010
Company: Endo Pharmaceuticals
Treatment for: Hypogonadism, Male

Fortesta (testosterone) Gel is a topical androgen indicated for replacement therapy in male hypogonadism.

• Endo Pharmaceuticals Receives FDA Approval for Fortesta (Testosterone) Gel as a Class III Product for Topical Use for Men With Low Testosterone
• Fortesta (testosterone) FDA Approval History