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New Drug Approvals Archive for 2011

See also: New Indications and Dosage Forms for 2011

Abstral (fentanyl) Sublingual Tablets

Date of Approval: January 7, 2011
Company: Orexo AB
Treatment for: Pain

Marketing Status: Discontinued

Abstral (fentanyl) is a sublingual opioid analgesic indicated for the management of breakthrough pain in cancer patients.

DaTscan (ioflupane I 123) Injection

Date of Approval: January 14, 2011
Company: GE Healthcare
Treatment for: Diagnosis and Investigation

DaTscan (ioflupane I 123 injection) is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS).

Natroba (spinosad) Topical Suspension

Date of Approval: January 18, 2011
Company: ParaPRO LLC
Treatment for: Lice

Natroba (spinosad) is a pediculicide indicated for the topical treatment of head lice infestations.

Viibryd (vilazodone) Tablets

Date of Approval: January 21, 2011
Company: Allergan, Inc.
Treatment for: Depression

Viibryd (vilazodone) is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist indicated for the treatment of major depressive disorder (MDD).

Gralise (gabapentin) Extended Release Tablets - formerly DM-1796

Date of Approval: January 28, 2011
Company: Depomed, Inc.
Treatment for: Postherpetic Neuralgia

Gralise (gabapentin) is an extended release, tablet formulation of the approved antiepileptic agent gabapentin, indicated for the once-daily treatment of post-herpetic neuralgia (PHN).

Makena (hydroxyprogesterone caproate) Injection - formerly Gestiva

Date of Approval: February 3, 2011
Company: Hologic, Inc.
Treatment for: Premature Labor

Makena (hydroxyprogesterone caproate) is a long acting form of natural progesterone for the prevention of preterm birth in pregnant women.

Corifact (factor XIII concentrate (human))

Date of Approval: February 17, 2011
Company: CSL Behring LLC
Treatment for: Factor XIII Deficiency

Corifact (factor XIII concentrate (human)) is a is a fibrin-stabilizing factor concentrate indicated to prevent bleeding in people with congenital Factor XIII deficiency.

Edarbi (azilsartan medoxomil) Tablets

Date of Approval: February 25, 2011
Company: Takeda Pharmaceutical Company Limited
Treatment for: High Blood Pressure

Edarbi (azilsartan medoxomil) is an angiotensin II receptor blocker (ARB) for the treatment of hypertension.

Daliresp (roflumilast) Tablets - formerly Daxas

Date of Approval: February 28, 2011
Company: Allergan, Inc.
Treatment for: COPD

Daliresp (roflumilast) is an orally administered phosphodiesterase 4 (PDE4) enzyme inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

Benlysta (belimumab) Injection

Date of Approval: March 10, 2011
Company: GlaxoSmithKline
Treatment for: Systemic Lupus Erythematosus, Lupus Nephritis

Benlysta (belimumab) is B-lymphocyte stimulator (BLyS)-specific inhibitor for the treatment of active systemic lupus erythematosus (SLE) and active lupus nephritis.

Gadavist (gadobutrol) Injection

Date of Approval: March 14, 2011
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Diagnosis and Investigation

Gadavist (gadobutrol) is a gadolinium-based contrast agent indicated for use in diagnostic magnetic resonance imaging (MRI).

(adenovirus type 4 and type 7 vaccine)

Date of Approval: March 16, 2011
Company: Barr Laboratories, Inc.
Treatment for: Infection Prophylaxis

Adenovirus type 4 and type 7 vaccine is an oral vaccine indicated for the prevention of febrile acute respiratory disease caused by adenovirus type 4 and type 7 in military populations.

Yervoy (ipilimumab) Injection

Date of Approval: March 25, 2011
Company: Bristol-Myers Squibb
Treatment for: Melanoma, Metastatic, Renal Cell Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Non-Small Cell Lung Cancer, Malignant Pleural Mesothelioma

Yervoy (ipilimumab) is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for the treatment of melanoma. Yervoy is also used in combination with Opdivo (nivolumab) for the treatment of advanced renal cell carcinoma, microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, and malignant pleural mesothelioma.

Caprelsa (vandetanib) Tablets

Date of Approval: April 6, 2011
Company: AstraZeneca
Treatment for: Thyroid Cancer

Caprelsa (vandetanib) is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable (non-operable) locally advanced or metastatic disease.

Horizant (gabapentin enacarbil) Extended Release Tablets - formerly Solzira

Date of Approval: April 6, 2011
Company: GlaxoSmithKline and XenoPort, Inc.
Treatment for: Restless Legs Syndrome, Postherpetic Neuralgia

Horizant (gabapentin enacarbil) is a gabapentin prodrug indicated for the once-daily treatment of restless legs syndrome and postherpetic neuralgia.

Sylatron (peginterferon alfa-2b)

Date of Approval: March 29, 2011
Company: Merck
Treatment for: Melanoma

Sylatron (peginterferon alfa-2b) is an alpha interferon indicated for the adjuvant treatment of melanoma.

Duexis (famotidine and ibuprofen) Tablets

Date of Approval: April 23, 2011
Company: Horizon Pharma, Inc.
Treatment for: Osteoarthritis, Rheumatoid Arthritis, NSAID-Induced Ulcer Prophylaxis

Duexis (ibuprofen and famotidine) is an NSAID and histamine H2-receptor antagonist combination indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper GI ulcers.

Zytiga (abiraterone) Tablets

Date of Approval: April 28, 2011
Company: Centocor Ortho Biotech Inc.
Treatment for: Prostate Cancer

Zytiga (abiraterone acetate) is a CYP17 inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer and metastatic high-risk castration-sensitive prostate cancer.

Tradjenta (linagliptin) Tablets

Date of Approval: May 2, 2011
Company: Boehringer Ingelheim Pharmaceuticals Inc.
Treatment for: Diabetes, Type 2

Tradjenta (linagliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Docefrez (docetaxel) for Injection

Date of Approval: May 3, 2011
Company: Sun Pharmaceutical Industries Ltd.
Treatment for: Breast Cancer, Non-Small Cell Lung Cancer, Prostate Cancer

Marketing Status: Discontinued

Docefrez (docetaxel) is a microtubule inhibitor indicated for the treatment of metastatic breast cancer, metastatic non-small cell lung cancer and hormone refractory metastatic prostate cancer.

Victrelis (boceprevir)

Date of Approval: May 13, 2011
Company: Merck
Treatment for: Hepatitis C

Marketing Status: Discontinued

Victrelis (boceprevir) is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C.

Edurant (rilpivirine) Tablets

Date of Approval: May 20, 2011
Company: Tibotec Pharmaceuticals
Treatment for: HIV Infection

Edurant (rilpivirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naïve).

Incivek (telaprevir) Tablets

Date of Approval: May 23, 2011
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Hepatitis C

Marketing Status: Discontinued

Incivek (telaprevir) is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated, in combination with peginterferon alfa and ribavirin, for the treatment of chronic hepatitis C (CHC).

Dificid (fidaxomicin)

Date of Approval: May 27, 2011
Company: Merck
Treatment for: Clostridioides difficile Infection

Dificid (fidaxomicin) is a macrolide antibacterial drug indicated for the treatment of Clostridioides difficile -associated diarrhea.

Potiga (ezogabine) Tablets

Date of Approval: June 10, 2011
Company: GlaxoSmithKline and Valeant Pharmaceuticals International
Treatment for: Seizures

Marketing Status: Discontinued

Potiga (ezogabine) is a potassium channel opener indicated for the adjunctive treatment of adults with partial-onset seizures.

Nulojix (belatacept) Injection

Date of Approval: June 15, 2011
Company: Bristol-Myers Squibb Company
Treatment for: Organ Transplant, Rejection Prophylaxis

Nulojix (belatacept) is a selective T-cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant.

Oxecta (oxycodone) Tablets - formerly Acurox

Date of Approval: June 17, 2011
Company: Pfizer Inc. and Acura Pharmaceuticals Inc.
Treatment for: Pain

Marketing Status: Discontinued

Oxecta (oxycodone hydrochloride) is an abuse-deterrent opioid analgesic formulation for the relief of moderate to severe pain.

Rectiv (nitroglycerin) Ointment

Date of Approval: June 21, 2011
Company: Allergan, Inc.
Treatment for: Anal Fissure and Fistula

Rectiv (nitroglycerin) is a topical ointment for the treatment of moderate to severe pain associated with chronic anal fissures.

LaViv (azficel-T)

Date of Approval: June 21, 2011
Company: Fibrocell Science, Inc.
Treatment for: Wrinkles

Azficel-T is an autologous cellular product indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults.

Zutripro (chlorpheniramine, hydrocodone and pseudoephedrine) Oral Solution

Date of Approval: June 8, 2011
Company: Cypress Pharmaceutical, Inc.
Treatment for: Cough and Nasal Congestion

Zutripro (chlorpheniramine, hydrocodone and pseudoephedrine) Oral Solution is a combination product containing an antitussive, an antihistamine, and a nasal decongestant indicated for the relief of cough and nasal congestion associated with the common cold and upper respiratory allergies.

Rezira (hydrocodone and pseudoephedrine) Oral Solution

Date of Approval: June 8, 2011
Company: Cypress Pharmaceutical, Inc.
Treatment for: Cough and Nasal Congestion

Rezira (hydrocodone and pseudoephedrine) Oral Solution is a combination product containing an antitussive and nasal decongestant indicated for the relief of cough and nasal congestion associated with the common cold.

Lazanda (fentanyl) Nasal Spray - formerly NasalFent

Date of Approval: June 30, 2011
Company: Archimedes Pharma
Treatment for: Pain

Lazanda (fentanyl) is an opioid analgesic nasal spray for the management of breakthrough pain in cancer patients.

Xarelto (rivaroxaban) Tablets and Oral Suspension

Date of Approval: July 1, 2011
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery, Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery, Prevention of Thromboembolism in Atrial Fibrillation, Coronary Artery Disease, Peripheral Arterial Disease, Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboembolism

Xarelto (rivaroxaban) is a factor Xa inhibitor used for the treatment and prevention of blood clots that are related to certain conditions involving the heart and blood vessels.

Arcapta (indacaterol) Neohaler - formerly QAB149

Date of Approval: July 1, 2011
Company: Novartis Pharmaceuticals Corp.
Treatment for: COPD

Arcapta (indacaterol inhalation powder) is a long-acting beta2-agonist (LABA) for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

Brilinta (ticagrelor) Tablets

Date of Approval: July 20, 2011
Company: AstraZeneca
Treatment for: Acute Coronary Syndrome, Coronary Artery Disease, Cardiovascular Risk Reduction, Ischemic Stroke, Prophylaxis

Brilinta (ticagrelor) is a P2Y12 platelet inhibitor indicated:
  • to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel.
    Brilinta also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS.
  • to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of Brilinta was established in a population with type 2 diabetes mellitus (T2DM).
  • to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA).

Anascorp (antivenom (centruroides scorpion)) Injection

Date of Approval: August 3, 2011
Treatment for: Scorpion Stings

Anascorp (Centruroides (Scorpion) Immune F(ab’)2 (Equine)) is an antivenom indicated for treatment of clinical signs of scorpion envenomation.

Complera (emtricitabine, rilpivirine and tenofovir disoproxil fumarate) Tablets

Date of Approval: August 10, 2011
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) is a combination of three antiretroviral medications indicated for the once daily treatment of HIV-1 infection in treatment-naïve adults.

Propel (mometasone furoate) Implant

Date of Approval: August 15, 2011
Company: Intersect ENT, Inc.
Treatment for: Sinusitis

Propel (mometasone furoate) is a corticosteroid implant offering localized, controlled drug delivery for chronic sinusitis patients.

Zelboraf (vemurafenib) Tablets

Date of Approval: August 17, 2011
Company: Genentech, Inc.
Treatment for: Melanoma, Metastatic

Zelboraf (vemurafenib) is a kinase inhibitor indicated for the treatment of patients with metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test, and for the treatment of patients with Erdheim-Chester Disease with BRAF V600 mutation.

Adcetris (brentuximab vedotin) Injection

Date of Approval: August 19, 2011
Company: Seattle Genetics, Inc.
Treatment for: Lymphoma, Hodgkin's Lymphoma, Mycosis Fungoides

Adcetris (brentuximab vedotin) is a CD30-directed antibody-drug conjugate (ADC) indicated for the treatment of adult patients with:

  • Previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine.
  • Classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
  • Classical Hodgkin lymphoma (cHL) after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates.
  • Previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone.
  • Systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.
  • Primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30- expressing mycosis fungoides (MF) who have received prior systemic therapy.

Firazyr (icatibant) Injection

Date of Approval: August 25, 2011
Company: Shire plc
Treatment for: Angioedema

Firazyr (icatibant) is a selective B2 bradykinin receptor antagonist indicated for the treatment of acute attacks of hereditary angioedema.

Xalkori (crizotinib) Capsules

Date of Approval: August 26, 2011
Company: Pfizer Inc.
Treatment for: Non-Small Cell Lung Cancer; Anaplastic Large Cell Lymphoma; Inflammatory Myofibroblastic Tumors

Xalkori (crizotinib) is an oral anaplastic lymphoma kinase (ALK) inhibitor for the treatment of ALK or ROS1-positive non-small cell lung cancer, ALK-positive anaplastic large cell lymphoma, and ALK-positive inflammatory myofibroblastic tumors.

Juvisync (simvastatin and sitagliptin) Tablets

Date of Approval: October 7, 2011
Company: Merck & Co., Inc.
Treatment for: Diabetes, Type 2, High Cholesterol, Familial Homozygous, High Cholesterol, Familial Heterozygous, Hypertriglyceridemia

Marketing Status: Discontinued

Juvisync (simvastatin and sitagliptin) is an HMG-CoA reductase inhibitor (statin) and dipeptidyl peptidase-4 (DPP-4) inhibitor fixed dose combination for the treatment of high cholesterol and type 2 diabetes.

Ferriprox (deferiprone) Tablets and Oral Solution

Date of Approval: October 14, 2011
Company: ApoPharma Inc.
Treatment for: Thalassemia, Iron Overload, Anemia, Sickle Cell

Ferriprox (deferiprone) is an iron chelator indicated for the treatment of transfusional iron overload in:
  • thalassemia syndromes
  • sickle cell disease or other anemias.
Ferriprox Tablets are indicated in adult and pediatric patients ≥8 years of age and Ferriprox Oral Solution is indicated in patients ≥3 years of age.

Onfi (clobazam) Tablets

Date of Approval: October 21, 2011
Company: Lundbeck Inc.
Treatment for: Lennox-Gastaut Syndrome

Onfi (clobazam) is a benzodiazepine antiepileptic drug for the treatment of patients with Lennox-Gastaut syndrome (LGS).

Exparel (bupivacaine liposome) Injectable Suspension

Date of Approval: October 28, 2011
Company: Pacira Pharmaceuticals, Inc.
Treatment for: Pain

Exparel (bupivacaine liposome injectable suspension) is a long-acting non-opioid local analgesic for postsurgical local analgesia, and for use as a nerve block (interscalene brachial plexus block) to provide pain relief following shoulder surgeries.

Forfivo XL (bupropion hydrochloride) Extended Release Tablets

Date of Approval: November 10, 2011
Company: IntelGenx Corp.
Treatment for: Depression

Forfivo XL (bupropion) is a high-strength formulation of the aminoketone antidepressant bupropion (contained in Wellbutrin) indicated for the treatment of major depressive disorder.

Belotero Balance (dermal filler)

Date of Approval: November 16, 2011
Company: Merz Pharmaceuticals, LLC
Treatment for: Facial Wrinkles

Belotero Balance (dermal filler) is a hyaluronic acid-based cohesive gel dermal filler for the correction of moderate to severe facial wrinkles and folds.

Jakafi (ruxolitinib) Tablets

Date of Approval: November 16, 2011
Company: Incyte Corporation
Treatment for: Myelofibrosis, Polycythemia Vera, Graft-versus-host disease

Jakafi (ruxolitinib) is a Janus kinase (JAK) inhibitor used for the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease.

Erwinaze (asparaginase Erwinia chrysanthemi) Injection

Date of Approval: November 18, 2011
Company: Jazz Pharmaceuticals
Treatment for: Acute Lymphoblastic Leukemia

Erwinaze (asparaginase Erwinia chrysanthemi) is an antineoplastic agent used to treat patients with acute lymphoblastic leukemia (ALL) who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegapargase chemotherapy drugs.

Eylea (aflibercept) Injection

Date of Approval: November 18, 2011
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetic Macular Edema

Eylea (aflibercept) is a VEGF inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

Intermezzo (zolpidem tartrate) Sublingual Tablets

Date of Approval: November 23, 2011
Company: Transcept Pharmaceuticals, Inc.
Treatment for: Insomnia

Marketing Status: Discontinued

Intermezzo is a low dose, fast acting, sublingual formulation of the hypnotic agent zolpidem, indicated for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.

Anturol (oxybutynin) Gel

Date of Approval: December 7, 2011
Company: Antares Pharma, Inc.
Treatment for: Overactive Bladder

Marketing Status: Discontinued

Anturol (oxybutynin) is an anticholinergic transdermal gel formulation indicated for the management of overactive bladder.

Edarbyclor (azilsartan medoxomil and chlorthalidone) Tablets

Date of Approval: December 20, 2011
Company: Takeda Pharmaceutical Company Limited
Treatment for: High Blood Pressure

Edarbyclor (azilsartan medoxomil and chlorthalidone) is a fixed-dose combination of an angiotensin II receptor blocker (ARB) and a diuretic, indicated for the treatment of hypertension.

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