New Drug Approvals Archive for 2009
See also: New Indications and Dosage Forms for 2009
AllerNaze (triamcinolone acetonide) Nasal Spray - formerly AllerNase
Date of Approval: January 7, 2009
Company: Collegium Pharmaceutical, Inc.
Treatment for: Allergic Rhinitis
Marketing Status: Discontinued
AllerNaze, formerly Tri-Nasal (triamcinolone acetonide, USP) is a reformulated aqueous intranasal steroid nasal spray indicated for the once daily treatment of nasal symptoms associated with both seasonal and perennial allergic rhinitis in adults and children twelve years of age and older.
Savella (milnacipran)
Date of Approval: January 14, 2009
Company: AbbVie Inc.
Treatment for: Fibromyalgia
Savella (milnacipran) is a selective serotonin and norepinephrine reuptake inhibitor indicated for the management of fibromyalgia.
RiaSTAP (Fibrinogen Concentrate (Human))
Date of Approval: January 16, 2009
Company: CSL Behring
Treatment for: Congenital Fibrinogen Deficiency
RiaSTAP (Fibrinogen Concentrate (Human)) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. RiaSTAP is not indicated for dysfibrinogenemia.
Gelnique (oxybutynin hydrochloride) Topical Gel - formerly OTG
Date of Approval: January 27, 2009
Company: AbbVie Inc.
Treatment for: Overactive Bladder
Gelnique (oxybutynin chloride) Gel is a transdermal antispasmodic which is applied to the skin once daily for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency.
Dexilant (dexlansoprazole) Delayed Release Capsules - formerly Kapidex
Date of Approval: January 30, 2009
Company: Takeda Pharmaceutical Company Limited
Treatment for: Erosive Esophagitis, GERD
Dexilant (dexlansoprazole) is a proton pump inhibitor with a novel delivery system approved for the treatment of erosive esophagitis and heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD).
Vectical (calcitriol) Ointment
Date of Approval: January 23, 2009
Company: Galderma Laboratories, L.P.
Treatment for: Psoriasis
Vectical Ointment is a Vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adults 18 years and older.
ATryn (Antithrombin (Recombinant))
Date of Approval: February 6, 2009
Company: GTC Biotherapeutics, Inc.
Treatment for: Antithrombin III Deficiency
ATryn (Antithrombin (Recombinant)) is a recombinant form of human antithrombin for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.
Uloric (febuxostat) Tablets
Date of Approval: February 13, 2009
Company: Takeda Pharmaceutical Company Limited
Treatment for: Gout
Uloric (febuxostat) is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout.
Edluar (zolpidem) Sublingual Tablets - formerly Sublinox
Date of Approval: March 13, 2009
Company: Orexo and Meda AB
Treatment for: Insomnia
Edluar (formerly Sublinox) is a fast-acting sublingual tablet formulation of the widely used drug zolpidem. Edluar is approved for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
Afinitor (everolimus) Tablets
Date of Approval: March 30, 2009
Company: Novartis AG
Treatment for: Renal Cell Carcinoma, Breast Cancer, Neuroendocrine Tumors
Afinitor (everolimus) is an oral once-daily inhibitor of mTOR indicated for the treatment of patients with advanced HR+, HER2- breast cancer; progressive neuroendocrine tumors of pancreatic origin (PNET); progressive neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin; advanced renal cell carcinoma; and subependymal giant cell astrocytoma (SEGA) and renal angiomyolipomas associated with tuberous sclerosis.
Ixiaro (Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed)
Date of Approval: March 30, 2009
Company: Intercell AG
Treatment for: Japanese Encephalitis Virus Prophylaxis
Ixiaro (Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed) is a purified, inactivated product for active immunization against viral infections of Japanese Encephalitis.
Coartem (artemether and lumefantrine) Tablets
Date of Approval: April 7, 2009
Company: Novartis
Treatment for: Malaria
Coartem (artemether and lumefantrine) is an artemisinin-based combination treatment for the treatment of malaria.
Ulesfia (benzyl alcohol) Lotion 5% - formerly Summers’ Lice Asphyxiator
Date of Approval: April 9, 2009
Company: Sciele Pharma, Inc.
Treatment for: Lice
Ulesfia (benzyl alcohol) Lotion is a non-toxic, insecticide-free head lice treatment which prevents lice from closing their spiracles (sophisticated breathing apparatus) thereby killing the lice by asphyxiation.
Simponi (golimumab) Injection
Date of Approval: April 24, 2009
Company: Centocor, Inc.
Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis
Simponi (golimumab) is a tumor necrosis factor (TNF) blocker indicated for the treatment of adult patients with:
- Moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate
- Active psoriatic arthritis (PsA) alone, or in combination with methotrexate
- Active ankylosing spondylitis (AS)
- Moderate to severe Ulcerative colitis (UC) with an inadequate response or intolerant to prior treatment or requiring continuous steroid therapy
- inducing and maintaining clinical response
- improving endoscopic appearance of the mucosa during induction
- inducing clinical remission
- achieving and sustaining clinical remission in induction responders
Dysport (abobotulinumtoxinA) Injection
Date of Approval: April 29, 2009
Company: Medicis and Ipsen
Treatment for: Cervical Dystonia, Facial Wrinkles, Upper Limb Spasticity, Lower Limb Spasticity
Dysport (abobotulinumtoxinA) is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for:
- the treatment of cervical dystonia in adults
- the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults < 65 years of age
- the treatment of spasticity in patients 2 years of age and older.
Exforge HCT (amlodipine, valsartan and hydrochlorothiazide) Tablets
Date of Approval: April 30, 2009
Company: Novartis AG
Treatment for: High Blood Pressure
Exforge HCT is a combination of the calcium channel blocker amlodipine, the angiotensin receptor blocker valsartan, and the diuretic hydrochlorothiazide indicated for the once-daily combination treatment of hypertension.
Cetraxal (ciprofloxacin otic) Solution
Date of Approval: May 1, 2009
Company: Salvat
Treatment for: Otitis Externa
Cetraxal (ciprofloxacin otic) is an antibiotic ear solution for the treatment of acute otitis externa.
Creon (pancrelipase) Delayed-Release Capsules
Date of Approval: April 30, 2009
Company: AbbVie Inc.
Treatment for: Pancreatic Exocrine Dysfunction
Creon (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions.
Cycloset (bromocriptine mesylate) Tablets
Date of Approval: May 5, 2009
Company: VeroScience and S2 Therapeutics, Inc.
Treatment for: Type 2 Diabetes
Cycloset (bromocriptine) is a first-in-class, central acting agent for the treatment of Type 2 Diabetes.
Fanapt (iloperidone) Tablets
Date of Approval: May 6, 2009
Company: Vanda Pharmaceuticals Inc.
Treatment for: Schizophrenia, Bipolar Disorder
Fanapt (iloperidone) is a 5HT2/D2 antagonist (atypical) antipsychotic for the treatment of schizophrenia, and the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
Samsca (tolvaptan) Tablets
Date of Approval: May 19, 2009
Company: Otsuka Pharmaceutical Development & Commercialization, Inc.
Treatment for: Hyponatremia
Samsca (tolvaptan) is an oral selective vasopressin antagonist for the treatment of patients with clinically significant hypervolemic and euvolemic hyponatremia.
Adcirca (tadalafil) Tablets
Date of Approval: May 22, 2009
Company: United Therapeutics Corporation
Treatment for: Pulmonary Arterial Hypertension
Adcirca (tadalafil) is a once-daily phosphodiesterase type 5 (PDE5) inhibitor for the treatment of pulmonary arterial hypertension (PAH).
Besivance (besifloxacin) Ophthalmic Suspension
Date of Approval: May 28, 2009
Company: Bausch & Lomb
Treatment for: Conjunctivitis, Bacterial
Besivance (besifloxacin ophthalmic suspension) is a topical quinolone antimicrobial for the treatment of bacterial conjunctivitis, commonly referred to as "pink eye."
Caldolor (ibuprofen) Intravenous Injection
Date of Approval: June 11, 2009
Company: Cumberland Pharmaceuticals Inc.
Treatment for: Pain, Fever
Caldolor (ibuprofen) is an intravenous formulation of the approved nonsteroidal anti-inflammatory drug ibuprofen for use in the treatment of pain and fever.
Zipsor (diclofenac potassium) Capsules
Date of Approval: June 16, 2009
Company: Xanodyne Pharmaceuticals, Inc.
Treatment for: Pain
Zipsor is a rapid release diclofenac potassium formulation for the treatment of patients with mild to moderate acute pain.
Ilaris (canakinumab) Injection
Date of Approval: June 17, 2009
Company: Novartis Pharmaceuticals Corporation
Treatment for: Cryopyrin-Associated Periodic Syndromes, Juvenile Idiopathic Arthritis, Familial Cold Autoinflammatory Syndrome, Muckle Wells Syndrome, Familial Mediterranean Fever, Still's Disease, Tumor Necrosis Factor Receptor Associated Periodic Syndrome, Hyperimmunoglobulin D Syndrome
Ilaris (canakinumab) is a human anti-interleukin-1β monoclonal antibody used for the treatment of Periodic Fever Syndromes, active Still’s disease, and gout flares.
Ozurdex (dexamethasone) Intravitreal Implant
Date of Approval: June 17, 2009
Company: AbbVie Inc.
Treatment for: Macular Edema, Uveitis
Ozurdex (dexamethasone intravitreal implant) is a sustained-release, corticosteroid implant for the treatment of macular edema, non-infectious uveitis, and diabetic macular edema.
Cambia (diclofenac potassium) for Oral Solution - formerly PRO-513
Date of Approval: June 17, 2009
Company: Kowa Pharmaceuticals America, Inc.
Treatment for: Migraine
Cambia (diclofenac potassium) is a non-steroidal anti-inflammatory drug combined with potassium bicarbonate for the treatment of acute migraine with or without aura in adults.
Feraheme (ferumoxytol) Intravenous Injection
Date of Approval: June 30, 2009
Company: AMAG Pharmaceuticals, Inc.
Treatment for: Anemia Due to Chronic Kidney Disease, Iron Deficiency Anemia
Feraheme (ferumoxytol) is an iron replacement therapy for the treatment of iron deficiency anemia in adult patients.
Multaq (dronedarone) Tablets
Date of Approval: July 1, 2009
Company: Sanofi-aventis
Treatment for: Atrial Fibrillation, Atrial Flutter
Multaq (dronedarone) is antiarrhythmic drug indicated to reduce the risk of cardiovascular hospitalization in patients with atrial fibrillation or atrial flutter.
Effient (prasugrel) Tablets
Date of Approval: July 10, 2009
Company: Cosette Pharmaceuticals, Inc.
Treatment for: Acute Coronary Syndrome
Effient (prasugrel) is an oral antiplatelet agent for the treatment of patients with acute coronary syndrome (ACS) who are managed with percutaneous coronary intervention including coronary stenting.
Plan B One-Step (levonorgestrel) Tablet
Date of Approval: July 10, 2009
Company: Teva Pharmaceuticals, Inc.
Treatment for: Emergency Contraception
Plan B One-Step (levonorgestrel) is a single dose emergency contraceptive pill to help prevent an unintended pregnancy after unprotected sex or contraceptive failure.
Sumavel DosePro (sumatriptan) Injection
Date of Approval: July 15, 2009
Company: Zogenix, Inc.
Treatment for: Migraine, Cluster Headaches
Marketing Status: Discontinued
Sumavel DosePro (sumatriptan injection) is a needle-free delivery system to treat acute migraine (with or without aura), and cluster headache.
Onsolis (fentanyl) Buccal Soluble Film
Date of Approval: July 16, 2009
Company: BioDelivery Sciences International, Inc.
Treatment for: Pain
Marketing Status: Discontinued
Onsolis (fentanyl) is an opioid agonist in a buccal formulation indicated for the management of breakthrough pain in cancer patients.
Acuvail (ketorolac tromethamine) Ophthalmic Solution
Date of Approval: July 22, 2009
Company: AbbVie Inc.
Treatment for: Postoperative Ocular Inflammation
Acuvail (ketorolac tromethamine) is a preservative-free formulation of ketorolac, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of pain and inflammation following cataract surgery.
Tyvaso (treprostinil) Inhalation Solution
Date of Approval: July 30, 2009
Company: United Therapeutics Corporation
Treatment for: Pulmonary Arterial Hypertension
Tyvaso (treprostinil) is a prostacyclin mimetic used for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
Colcrys (colchicine) Tablets
Date of Approval: July 29, 2009
Company: Mutual Pharmaceutical Company, Inc.
Treatment for: Gout, Familial Mediterranean Fever, Gout, Prophylaxis, Gout, Acute
Colcrys (colchicine) is compound derived from the dried seeds of the autumn crocus or meadow saffron (Colchicum autumnale). Colcrys is approved for the prophylaxis and treatment of acute gout flares, and for the treatment of patients with familial Mediterranean fever.
Onglyza (saxagliptin) Tablets
Date of Approval: July 31, 2009
Company: AstraZeneca
Treatment for: Type 2 Diabetes
Onglyza (saxagliptin) is a dipeptidyl peptidase-4 (DPP4) inhibitor indicated for the treatment of type 2 diabetes mellitus in adults.
Invega Sustenna (paliperidone palmitate) Extended-Release Injectable Suspension
Date of Approval: July 31, 2009
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Schizophrenia, Schizoaffective Disorder
Invega Sustenna (1-month paliperidone palmitate) is a long-acting injectable atypical antipsychotic indicated for the treatment of schizophrenia and schizoaffective disorder.
Xerese (acyclovir and hydrocortisone) Topical Cream - formerly Lipsovir
Date of Approval: July 31, 2009
Company: Meda Pharmaceuticals Inc.
Treatment for: Cold Sores
Xerese (acyclovir and hydrocortisone) is a topical antiviral and anti-inflammatory combination for the prevention and treatment of cold sores.
Livalo (pitavastatin) Tablets
Date of Approval: August 3, 2009
Company: Kowa Company, Ltd.
Treatment for: High Cholesterol
Livalo (pitavastatin) is an HMG CoA reductase inhibitor indicated for the primary treatment of hypercholesterolemia and combined dyslipidemia.
Embeda (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules
Date of Approval: August 13, 2009
Company: King Pharmaceuticals , Inc.
Treatment for: Pain
Embeda is an abuse-deterrent, extended-release morphine preparation for the treatment of chronic pain.
Saphris (asenapine) Sublingual Tablets
Date of Approval: August 13, 2009
Company: AbbVie Inc.
Treatment for: Schizophrenia, Bipolar Disorder
Saphris (asenapine) is an atypical antipsychotic for the treatment of schizophrenia and acute mania or mixed episodes associated with bipolar I disorder.
Extavia (interferon beta-1b)
Date of Approval: August 14, 2009
Treatment for: Multiple Sclerosis
Extavia is a branded version of interferon beta-1b, a first-line disease-modifying therapy that has been a standard-of-care for multiple sclerosis for many years. Extavia is indicated for the treatment of MS patients with relapsing forms of the disease and for newly diagnosed patients.
Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)) Solution for Intramuscular Injection
Date of Approval: August 19, 2009
Company: GlaxoSmithKline
Treatment for: Haemophilus influenzae Prophylaxis
Hiberix is a vaccine indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b. Hiberix is approved for use in children aged six weeks through four years of age (prior to fifth birthday).
Sabril (vigabatrin) Tablets and Oral Solution
Date of Approval: August 21, 2009
Company: Lundbeck Inc.
Treatment for: Seizures, Infantile Spasms
Sabril (vigabatrin) is an oral irreversible GABA-transaminase inhibitor for the treatment of infantile spasms and refractory complex partial seizures.
Zenpep (pancrelipase) Capsules - formerly Zentase
Date of Approval: August 27, 2009
Company: Allergan, Inc.
Treatment for: Pancreatic Exocrine Dysfunction
Zenpep (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.
Intuniv (guanfacine) Extended Release Tablets - formerly Connexyn
Date of Approval: September 2, 2009
Company: Shire plc
Treatment for: Attention-Deficit Hyperactivity Disorder
Intuniv (guanfacine) is a nonstimulant selective alpha-2A-receptor agonist for the treatment of children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).
Metozolv ODT (metoclopramide) Orally Disintegrating Tablets
Date of Approval: September 4, 2009
Company: Salix Pharmaceuticals, Ltd.
Treatment for: GERD, Gastroparesis
Marketing Status: Discontinued
Metozolv ODT is a fast–dissolving formulation of metoclopramide for the short–term treatment of adults with gastroesophageal reflux and for the relief of symptoms associated with diabetic gastroparesis.
Bepreve (bepotastine) Ophthalmic Solution
Date of Approval: September 8, 2009
Company: ISTA Pharmaceuticals, Inc.
Treatment for: Conjunctivitis, Allergic
Bepreve (bepotastine ophthalmic solution) is an antihistamine and mast cell stabilizer for treatment of the symptoms of allergic conjunctivitis.
Vibativ (telavancin) Injection
Date of Approval: September 11, 2009
Company: Theravance Inc.
Treatment for: Skin and Structure Infection, Pneumonia
Vibativ (telavancin) is a bactericidal, once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections (cSSSI), and hospital-acquired and ventilator-associated bacterial pneumonia.
Zirgan (ganciclovir) Ophthalmic Gel
Date of Approval: September 15, 2009
Company: Sirion Therapeutics, Inc.
Treatment for: Herpetic Keratitis
Zirgan (ganciclovir ophthalmic gel) is a topical ophthalmic antiviral preparation for the treatment of acute herpetic keratitis (dendritic ulcers).
Influenza A (H1N1) 2009 Monovalent Vaccine (H1N1 influenza virus vaccine)
Date of Approval: September 15, 2009
Company: CSL Limited; Novartis Vaccines and Diagnostics Limited; Sanofi Pasteur, Inc.; MedImmune LLC
Treatment for: Prevention of H1N1 Influenza
Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.
Valturna (aliskiren and valsartan) Tablets
Date of Approval: September 16, 2009
Company: Novartis
Treatment for: High Blood Pressure
Marketing Status: Discontinued
Valturna is a combination of aliskiren (a direct renin inhibitor) and valsartan (an angiotensin II receptor blocker) indicated for the treatment of high blood pressure.
Folotyn (pralatrexate) Injection
Date of Approval: September 24, 2009
Company: Allos Therapeutics, Inc.
Treatment for: Peripheral T-cell Lymphoma
Folotyn (pralatrexate) is a folate analogue metabolic inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
Stelara (ustekinumab) Injection
Date of Approval: September 25, 2009
Company: Janssen Biotech, Inc.
Treatment for: Psoriasis, Psoriatic Arthritis, Crohn's Disease, Maintenance, Ulcerative Colitis
Stelara (ustekinumab) is a human interleukin-12 and -23 antagonist indicated for the treatment of moderate to severe plaque psoriasis (Ps), active psoriatic arthritis (PsA), moderately to severely active Crohn’s disease (CD), and moderately to severely active ulcerative colitis.
Berinert (C1 esterase inhibitor (human)) Injection
Date of Approval: October 9, 2009
Company: CSL Behring
Treatment for: Hereditary Angioedema
Berinert (C1-esterase inhibitor (human)) is a plasma derived C1 esterase inhibitor indicated for the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) in adult and pediatric patients.
Cervarix (human papillomavirus bivalent (types 16 and 18) vaccine, recombinant) Injection
Date of Approval: October 16, 2009
Company: GlaxoSmithKline
Treatment for: Human Papillomavirus Prophylaxis
Marketing Status: Discontinued
Cervarix (human papillomavirus bivalent (types 16 and 18) is a is a preventative cervical cancer vaccine for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 in girls and young women (aged 10-25).
Twynsta (telmisartan and amlodipine) Tablets
Date of Approval: October 16, 2009
Company: Boehringer Ingelheim Pharmaceuticals Inc.
Treatment for: High Blood Pressure
Twynsta (telmisartan/amlodipine) is an angiotensin II receptor blocker (ARB) and a dihydropyridine calcium channel blocker (DHP-CCB) combination product indicated for the treatment of hypertension alone or with other antihypertensive agents.
Votrient (pazopanib) Tablets
Date of Approval: October 19, 2009
Company: GlaxoSmithKline
Treatment for: Renal Cell Carcinoma, Soft Tissue Sarcoma
Votrient (pazopanib) is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma and advanced soft tissue sarcoma.
Arzerra (ofatumumab) Injection
Date of Approval: October 26, 2009
Company: GlaxoSmithKline
Treatment for: Chronic Lymphocytic Leukemia
Arzerra (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia.
Pennsaid (diclofenac sodium) Topical Solution
Date of Approval: November 4, 2009
Company: Nuvo Research Inc.
Treatment for: Osteoarthritis
Pennsaid is a topical non-steroidal anti-inflammatory drug (NSAID) used for the treatment of signs and symptoms of osteoarthritis of the knee.
Istodax (romidepsin) for Injection
Date of Approval: November 5, 2009
Company: Gloucester Pharmaceuticals
Treatment for: Cutaneous T-cell Lymphoma
Istodax (romidepsin) a histone deacetylase (HDAC) inhibitor indicated the treatment of cutaneous T-cell lymphoma and peripheral T-cell lymphoma.
Lysteda (tranexamic acid) Tablets - formerly XP12B
Date of Approval: November 13, 2009
Company: Xanodyne Pharmaceuticals, Inc.
Treatment for: Menorrhagia
Lysteda (tranexamic acid) is an antifibrinolytic agent for the treatment of women with menorrhagia, heavy menstrual bleeding (HMB), and its accompanying symptoms.
Qutenza (capsaicin) Transdermal Patch
Date of Approval: November 16, 2009
Company: Averitas Pharma, Inc.
Treatment for: Neuropathic Pain, Postherpetic Neuralgia, Diabetic Peripheral Neuropathy
Qutenza (capsaicin) is a TRPV1 channel agonist indicated for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet.
Agriflu (influenza virus vaccine, inactivated) Injection
Date of Approval: November 27, 2009
Company: Novartis Vaccines and Diagnostics, Inc.
Treatment for: Influenza Prophylaxis
Agriflu (influenza virus vaccine, inactivated) is a vaccine indicated for the active immunization of adults 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.
Zegerid OTC (omeprazole and sodium bicarbonate) Capsules
Date of Approval: December 1, 2009
Company: Merck & Co. and Santarus Inc.
Treatment for: Heartburn
Zegerid OTC (omeprazole and sodium bicarbonate) is an over-the-counter version of the prescription heartburn drug Zegerid.
Kalbitor (ecallantide) Injection - formerly DX-88
Date of Approval: December 1, 2009
Company: Dyax Corp.
Treatment for: Angioedema
Kalbitor (ecallantide) is plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema in patients 16 years of age and older.
Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human)) Injection
Date of Approval: December 4, 2009
Company: Octapharma USA
Treatment for: von Willebrand Disease, Hemophilia A
Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human)) is used in the management of von Willebrand disease and hemophilia A.
Zyprexa Relprevv (olanzapine) for Extended Release Injectable Suspension
Date of Approval: December 11, 2009
Company: Lilly
Treatment for: Schizophrenia
Zyprexa Relprevv (olanzapine) is a long-acting atypical antipsychotic for intramuscular injection indicated for the treatment of schizophrenia.
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