New Drug Approvals Archive for 2010
See also: New Indications and Dosage Forms 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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
Pradaxa capsules are indicated:
- 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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
New drug approvals archive
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.