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New Additions to for 2009

The following 73 drugs were added to the database in 2009.

Dec 28, 2009 - Wilate ((von Willebrand Factor/Coagulation Factor VIII Complex [Human]) is an injection that may be used to treat episodes of bleeding associated with von Willebrand disease (VWD) in adults and children and hemophilia A in adults and adolescents.

Zyprexa Relprevv
Dec 28, 2009 - Zyprexa Relprevv (olanzapine) is a long-acting atypical antipsychotic for intramuscular injection indicated for the treatment of schizophrenia.

Zegerid OTC
Dec 28, 2009 - Zegerid OTC (omeprazole and sodium bicarbonate) is an over-the-counter version of the prescription heartburn medicine Zegerid.

Dec 28, 2009 - 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.

Nov 28, 2009 - Qutenza is a capsaicin transdermal patch for the management of neuropathic pain associated with postherpetic neuralgia (PHN) and neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet.

Nov 17, 2009 - Lysteda (tranexamic acid) is an antifibrinolytic agent for the treatment of women with menorrhagia, heavy menstrual bleeding (HMB), and its accompanying symptoms.

Nov 12, 2009 - Pennsaid is a topical non-steroidal anti-inflammatory drug (NSAID) used for the treatment of signs and symptoms of osteoarthritis of the knee.

Nov 6, 2009 - Istodax (romidepsin) a histone deacetylase (HDAC) inhibitor indicated the treatment of cutaneous T-cell lymphoma.

Oct 31, 2009 - 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).

Oct 31, 2009 - Votrient (pazopanib) is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma.

Oct 31, 2009 - Arzerra (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia.

Oct 26, 2009 - 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.

Oct 12, 2009 - Berinert (C1-esterase inhibitor (human)) is a plasma derived C1 Esterase Inhibitor indicated for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adult and adolescent patients.

Sep 29, 2009 - Stelara (ustekinumab) is a human monoclonal antibody for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

Influenza A (H1N1) 2009 Monovalent Vaccine
Sep 29, 2009 - Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons ages 18 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.

Sep 29, 2009 - Zirgan (ganciclovir ophthalmic gel) is a topical ophthalmic antiviral preparation for the treatment of acute herpetic keratitis (dendritic ulcers).

Sep 29, 2009 - 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.

Sep 25, 2009 - Folotyn (pralatrexate) is a folate analogue metabolic inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

Sep 17, 2009 - 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.

Sep 15, 2009 - Bepreve (bepotastine ophthalmic solution) is an antihistamine and mast cell stabilizer for treatment of the symptoms of allergic conjunctivitis.

Metozolv ODT
Sep 15, 2009 - 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.

Sep 15, 2009 - Intuniv (guanfacine) is a nonstimulant selective alpha-2A-receptor agonist for the treatment of children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).

Aug 29, 2009 - Zenpep (pancrealipase) 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.

Aug 28, 2009 - Sabril (vigabatrin) is an oral irreversible GABA-transaminase inhibitor for the treatment of Infantile Spasms and refractory complex partial seizures.

Aug 27, 2009 - Hiberix is 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 15 months through 4 years of age (prior to fifth birthday).

Aug 27, 2009 - 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.

Aug 27, 2009 - Saphris (asenapine) is an atypical antipsychotic for the treatment of schizophrenia and acute mania or mixed episodes associated with bipolar I disorder.

Aug 26, 2009 - Livalo (pitavastatin) is an HMG CoA reductase inhibitor indicated for the primary treatment of hypercholesterolemia and combined dyslipidemia.

Aug 26, 2009 - Lipsovir is topical combination of hydrocortisone (an anti-inflammatory agent) and acyclovir (an antiviral agent) for the prevention and treatment of cold sores.

Aug 23, 2009 - Embeda is an abuse-deterrent, extended-release morphine preparation for the treatment of chronic pain.

Aug 23, 2009 - Nucynta (tapentadol) is a centrally acting oral analgesic indicated for the relief of moderate to severe acute pain.

Aug 1, 2009 - Onglyza (saxagliptin) is a dipeptidyl peptidase-4 (DPP4) inhibitor indicated for the treatment of type 2 diabetes mellitus in adults.

Aug 1, 2009 - Colcrys (colchicine) is compound derived from the dried seeds of the autumn crocus or meadow saffron (Colchicum autumnale). Colchicine has been used by healthcare practitioners for many years to treat gout but had not been approved by the FDA. Colcrys is approved to treat acute flares in patients with gout, and patients with familial Mediterranean fever.

Jul 31, 2009 - Tyvaso (treprostinil) is an inhaled prostanoid analogue indicated for the treatment of pulmonary arterial hypertension.

Jul 30, 2009 - 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.

Sumavel DosePro
Jul 30, 2009 - Sumavel DosePro (sumatriptan injection) is a needle-free delivery system to treat acute migraine, with or without aura, and cluster headache.

Jul 18, 2009 - 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.

Jul 17, 2009 - Onsolis consists of a dissolvable polymer film formulated with the opioid narcotic fentanyl for application to the buccal mucosa (inner lining of the cheek). Onsolis is used for the management of breakthrough pain in patients with cancer.

Jul 17, 2009 - Dysport (abobotulinumtoxinA) is an acetylcholine release inhibitor and neuromuscular blocking agent for the treatment of cervical dystonia, for the temporary improvement in the appearance of moderate to severe glabellar lines, and for the treatment of upper and lower limb spasticity.

Jul 15, 2009 - Ilaris (canakinumab) is a human anti-interleukin-1β monoclonal antibody for the treatment of Periodic Fever Syndromes (Cryopyrin-Associated Periodic Syndromes, Tumor Necrosis Factor Receptor Associated Periodic Syndrome, Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency, Familial Mediterranean Fever) and active Systemic Juvenile Idiopathic Arthritis.

Plan B One-Step
Jul 14, 2009 - Plan B One-Step (levonorgestrel) is a single dose emergency contraceptive pill to help prevent an unintended pregnancy after unprotected sex or contraceptive failure. Plan B One-Step is available over-the-counter (OTC).

Jul 13, 2009 - Feraheme (ferumoxytol) is an iron replacement therapy for the treatment of iron deficiency anemia in adults.

Jul 12, 2009 - 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.

Jul 8, 2009 - Multaq (dronedarone) is antiarrhythmic drug indicated to reduce the risk of cardiovascular hospitalization in patients with atrial fibrillation or atrial flutter.

Jun 24, 2009 - 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.

Jun 24, 2009 - Ozurdex (dexamethasone intravitreal implant) is a sustained-release, potent steroid implant for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

Jun 24, 2009 - Zipsor is a rapid release diclofenac potassium formulation for the treatment of patients with mild to moderate acute pain.

Jun 13, 2009 - Caldolor is an intravenous formulation of ibuprofen indicated for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever in adults.

Jun 1, 2009 - Besivance (besifloxacin ophthalmic suspension) is a topical quinolone antimicrobial for the treatment of bacterial conjunctivitis, commonly referred to as "pink eye."

May 26, 2009 - Adcirca (tadalafil) is a once-daily phosphodiesterase type 5 (PDE5) inhibitor for the treatment of pulmonary arterial hypertension (PAH).

May 25, 2009 - Samsca (tolvaptan) is an oral selective vasopressin antagonist for the treatment of patients with clinically significant hypervolemic and euvolemic hyponatremia.

May 25, 2009 - Fanapt (iloperidone) is a 5HT2/D2 antagonist (atypical) antipsychotic for the treatment of schizophrenia.

May 14, 2009 - Cetraxal (ciprofloxacin otic) is an antibiotic ear solution for the treatment of acute otitis externa.

May 14, 2009 - Cycloset (bromocriptine) is a first-in-class, central acting agent for the treatment of Type 2 Diabetes.

May 7, 2009 - Tapentadol is a centrally acting oral analgesic indicated for the relief of moderate to severe acute pain.

Exforge HCT
May 5, 2009 - 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.

Apr 27, 2009 - Simponi (golimumab) is a human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody administered once-monthly for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis.

Apr 26, 2009 - Coartem (artemether and lumefantrine) is an artemisinin-based combination treatment for the treatment of malaria.

Apr 26, 2009 - Ixiaro (Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed) is a purified, inactivated product for active immunization against viral infections of Japanese Encephalitis.

Mar 30, 2009 - Edluar 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.

Feb 17, 2009 - Uloric (febuxostat) is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout.

Feb 9, 2009 - 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.

Feb 3, 2009 - Vectical Ointment is a Vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adults 18 years and older.

Feb 2, 2009 - Kapidex (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).

Jan 29, 2009 - Ryzolt (tramadol HCl extended release tablets) is a once-daily analgesic indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

Jan 29, 2009 - RiaSTAP (Fibrinogen Concentrate (Human)) is lyophilized fibrinogen for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Jan 28, 2009 - 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.

Jan 22, 2009 - 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.

Jan 22, 2009 - Degarelix is an injectable gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for patients with advanced prostate cancer. Potential trade names for degarelix are still under review with the FDA.

Jan 15, 2009 - Milnacipran is a selective serotonin and norepinephrine reuptake inhibitor indicated for the management of fibromyalgia.

Jan 8, 2009 - Zolpimist is an oral spray formulation of zolpidem, the drug contained in Ambien. Zolpimist is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

Jan 8, 2009 - Epiduo (adapalene and benzoyl peroxide) Gel is a once-daily, topical acne treatment that combines the well-tolerated retinoid adapalene, and benzoyl peroxide, a well-known antimicrobial.

Jan 5, 2009 - Nexterone (amiodarone HCl) Injection is a cosolvent free formulation of the antiarrhythmic agent Amiodarone IV, originally marketed in the US by Wyeth as Cordarone Intravenous. Nexterone is indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

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