New Drug Approvals Archive 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.

• Collegium Pharmaceutical Announces FDA Approval of AllerNaze, a Nasal Inhaled Steroid for the Treatment of Allergic Rhinitis
• AllerNaze (triamcinolone acetonide) FDA Approval History

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.

• Forest and Cypress Announce FDA Approval of Savella for the Management of Fibromyalgia
• Savella (milnacipran) FDA Approval History

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.

• CSL Behring Receives FDA Approval of RiaSTAP, First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency
• RiaSTAP (Fibrinogen Concentrate (Human)) FDA Approval History

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.

• Watson's Gelnique (oxybutynin chloride) Gel 10% Approved by FDA for the Treatment of Overactive Bladder
• Gelnique (oxybutynin hydrochloride) FDA Approval History

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).

• FDA Approves Kapidex (dexlansoprazole) for the Treatment of GERD
• Dexilant (dexlansoprazole) FDA Approval History

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.

• Galderma Wins FDA Approval for Vectical Ointment, a Novel Topical Therapy for Mild-to-Moderate Plaque Psoriasis
• Vectical (calcitriol) FDA Approval History

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.

• ATryn (Antithrombin [Recombinant]) Approved by the FDA
• ATryn (Antithrombin (Recombinant)) FDA Approval History

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.

• FDA Approves Uloric (febuxostat) for the Chronic Management of Hyperuricemia in Patients with Gout
• Uloric (febuxostat) FDA Approval History

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.

• Orexo's Edluar (formerly Sublinox) receives FDA approval for the treatment of insomnia
• Edluar (zolpidem) FDA Approval History

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.

• Afinitor approved in US as first treatment for patients with advanced kidney cancer after failure of either sunitinib or sorafenib
• Afinitor (everolimus) FDA Approval History

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.

• Intercell Announces FDA Approval of Ixiaro, a Novel Vaccine to Prevent Japanese Encephalitis
• Ixiaro (Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed) FDA Approval History

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.

• Coartem receives FDA approval becoming first artemisinin-based combination treatment (ACT) for malaria in the US
• Coartem (artemether and lumefantrine) FDA Approval History

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.

• Sciele Pharma Announces FDA Approval of Benzyl Alcohol Lotion 5%, First Prescription Non-Neurotoxic Head Lice Treatment
• Ulesfia (benzyl alcohol) FDA Approval History

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

• Simponi (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
• Simponi (golimumab) FDA Approval History

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.

• FDA Approves Dysport (abobotulinumtoxinA) for Cervical Dystonia and Glabellar Lines
• Dysport (abobotulinumtoxinA) FDA Approval History

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.

• FDA approves Exforge HCT - the only high blood pressure treatment to combine three medications in a single pill
• Exforge HCT (amlodipine, valsartan and hydrochlorothiazide) FDA Approval History

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.

• FDA Approves Cetraxal Otic Solution
• Cetraxal (ciprofloxacin otic) FDA Approval History

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.

• Creon (pancrelipase) Delayed-Release Capsules First and Only Pancreatic Enzyme Product to Receive FDA Approval Under New Guidelines
• Creon (pancrelipase) FDA Approval History

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.

• VeroScience Announces FDA Approval of Cycloset for Treatment of Type 2 Diabetes
• Cycloset (bromocriptine mesylate) FDA Approval History

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.

• FDA Approves Fanapt to Treat Schizophrenia
• Fanapt (iloperidone) FDA Approval History

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.

• FDA Approves Samsca (tolvaptan), the First and Only Oral Vasopressin Antagonist to Treat Patients With Clinically Significant Hypervolemic and Euvolemic Hyponatremia
• Samsca (tolvaptan) FDA Approval History

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).

• FDA Approves Adcirca (tadalafil) Tablets for the Treatment of Pulmonary Arterial Hypertension
• Adcirca (tadalafil) FDA Approval History

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."

• Bausch & Lomb Receives FDA Approval of Besivance, New Topical Ophthalmic Antibacterial for the Treatment of Bacterial Conjunctivitis ('Pink Eye')
• Besivance (besifloxacin) FDA Approval History

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.

• Cumberland Pharmaceuticals Announces FDA Approval of Caldolor
• Caldolor (ibuprofen) FDA Approval History

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.

• Xanodyne Receives Approval From the U.S. Food and Drug Administration for Zipsor (diclofenac potassium) Liquid Filled Capsules
• Zipsor (diclofenac potassium) FDA Approval History

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.

• New Biological Therapy Ilaris Approved In US To Treat Children And Adults With CAPS, A Serious Life-Long Auto-Inflammatory Disease
• Ilaris (canakinumab) FDA Approval History

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.

• Allergan Receives FDA Approval for Ozurdex Biodegradable, Injectable Steroid Implant with Extended Drug Release for Retinal Disease
• Ozurdex (dexamethasone) FDA Approval History

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.

• FDA Approves Cambia for Migraine
• Cambia (diclofenac potassium) FDA Approval History

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.

• FDA Approves Feraheme to Treat Iron Deficiency Anemia in Adult Chronic Kidney Disease Patients
• Feraheme (ferumoxytol) FDA Approval History

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.

• FDA Approves Multaq for Patients with Atrial Fibrillation or Atrial Flutter
• Multaq (dronedarone) FDA Approval History

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.

• Daiichi Sankyo and Lilly Receive U.S. FDA Approval for Effient
• Effient (prasugrel) FDA Approval History

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.

• FDA Approves Plan B One-Step, a New One-Pill Emergency Contraceptive
• Plan B One-Step (levonorgestrel) FDA Approval History

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.

• Sumavel DosePro (sumatriptan injection) Approved by FDA for Acute Migraine and Cluster Headache: First Product Featuring Novel DosePro Needle-Free Delivery System
• Sumavel DosePro (sumatriptan) FDA Approval History

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.

• BioDelivery Sciences and Meda Announce FDA Approval of Onsolis
• Onsolis (fentanyl) FDA Approval History

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.

• Allergan Receives FDA Approval for Acuvail Ophthalmic Solution for the Treatment of Pain and Inflammation Following Cataract Surgery
• Acuvail (ketorolac tromethamine) FDA Approval History

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.

• FDA Approves Tyvaso (treprostinil) Inhalation Solution for the Treatment of Pulmonary Arterial Hypertension
• Tyvaso (treprostinil) FDA Approval History

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.

• FDA Approves Colcrys (colchicine) for Acute Gout, Mediterranean Fever
• Colcrys (colchicine) FDA Approval History

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.

• FDA Approves Onglyza (saxagliptin) for Type 2 Diabetes
• Onglyza (saxagliptin) FDA Approval History

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.

• FDA Approves Invega Sustenna for the Acute and Maintenance Treatment of Schizophrenia
• Invega Sustenna (paliperidone palmitate) FDA Approval History

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.

• The US FDA approves Lipsovir for marketing and sales in US
• Xerese (acyclovir and hydrocortisone) FDA Approval History

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.

• FDA Approves Livalo for Primary Hypercholesterolemia and Combined Dyslipidemia
• Livalo (pitavastatin) FDA Approval History

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.

• FDA Approves Embeda For Management of Moderate to Severe Chronic Pain
• Embeda (morphine sulfate and naltrexone hydrochloride) FDA Approval History

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.

• Schering-Plough Announces FDA Approval of Saphris (asenapine)
• Saphris (asenapine) FDA Approval History

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.

• US FDA Approves Extavia - the First in a New Portfolio of Planned MS Therapies from Novartis to Help Patients with This Devastating Disease
• Extavia (interferon beta-1b) FDA Approval History

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).

• FDA Approves GSK's Hib Vaccine, Hiberix
• Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)) FDA Approval History

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.

• Lundbeck Inc. Announces FDA Marketing Approval for Sabril for the Treatment of Two Difficult-to-Treat Epilepsies
• Sabril (vigabatrin) FDA Approval History

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.

• Eurand Granted FDA Approval for Zenpep
• Zenpep (pancrelipase) FDA Approval History

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).

• Shire Announces FDA Approval of Once-Daily Intuniv (guanfacine) Extended Release Tablets for the Treatment of ADHD in Children and Adolescents Aged 6 to 17
• Intuniv (guanfacine) FDA Approval History

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.

• Salix Receives FDA Marketing Approval for Metozolv ODT (Orally Disintegrating Tablets) for Relief of Diabetic Gastroparesis and Symptomatic Documented GERD
• Metozolv ODT (metoclopramide) FDA Approval History

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.

• Ista Pharmaceuticals' Bepreve Receives FDA Approval for the Treatment of Ocular Itching Due to Allergies
• Bepreve (bepotastine) FDA Approval History

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.

• Theravance and Astellas Announce FDA Approval of Vibativ (telavancin) for the Treatment of Complicated Skin and Skin Structure Infections
• Vibativ (telavancin) FDA Approval History

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).

• Sirion Therapeutics Announces FDA Approval of Zirgan (ganciclovir ophthalmic gel) 0.15% for Herpetic Keratitis
• Zirgan (ganciclovir) FDA Approval History

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.

• FDA Approves Vaccines for 2009 H1N1 Influenza Virus
• Influenza A (H1N1) 2009 Monovalent Vaccine (H1N1 influenza virus vaccine) FDA Approval History

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.

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

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).

• FDA Approves Folotyn (pralatrexate) for Treatment of Peripheral T-cell Lymphoma
• Folotyn (pralatrexate) FDA Approval History

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.

• FDA Approves Stelara (ustekinumab) to Treat Psoriasis
• Stelara (ustekinumab) FDA Approval History

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.

• CSL Behring Announces FDA Approval of Berinert, First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S.
• Berinert (C1 esterase inhibitor (human)) FDA Approval History

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).

• FDA approves Cervarix, GlaxoSmithKline's cervical cancer vaccine
• Cervarix (human papillomavirus bivalent (types 16 and 18) vaccine, recombinant) FDA Approval History

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.

• FDA Approves Twynsta (telmisartan/amlodipine) for Hypertension
• Twynsta (telmisartan and amlodipine) FDA Approval History

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.

• FDA Approves GlaxoSmithKline’s Votrient for Advanced Renal Cell Cancer
• Votrient (pazopanib) FDA Approval History

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.

• FDA Approves Arzerra (ofatumumab) for Chronic Lymphocytic Leukemia
• Arzerra (ofatumumab) FDA Approval History

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.

• FDA Approves Pennsaid Topical Solution
• Pennsaid (diclofenac sodium) FDA Approval History

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.

• FDA Approves Gloucester Pharmaceuticals' Istodax for Patients with Cutaneous T-cell Lymphoma
• Istodax (romidepsin) FDA Approval History

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.

• Xanodyne Announces FDA Approval of Lysteda (Tranexamic Acid) for Treatment of Women with Heavy Menstrual Bleeding
• Lysteda (tranexamic acid) FDA Approval History

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.

• NeurogesX Receives FDA Approval of Qutenza (capsaicin) 8% Patch for Treatment of Postherpetic Neuralgia (PHN)
• Qutenza (capsaicin) FDA Approval History

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.

• FDA Approves Agriflu Seasonal Influenza Vaccine
• Agriflu (influenza virus vaccine, inactivated) FDA Approval History

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.

• FDA Approves OTC Version Of Heartburn Drug Zegerid
• Zegerid OTC (omeprazole and sodium bicarbonate) FDA Approval History

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.

• Dyax Announces FDA Approval of Kalbitor (ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema in Patients 16 Years of Age and Older
• Kalbitor (ecallantide) FDA Approval History

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.

• Octapharma USA Announces FDA Approval of Wilate - the First Replacement Therapy Developed Specifically for von Willebrand Disease
• Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human)) FDA Approval History

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.

• FDA Approves Lilly's Zyprexa Relprevv for Treatment of Schizophrenia in Adults
• Zyprexa Relprevv (olanzapine) FDA Approval History