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Selected Drug Approvals 2006 - 2011

Organized by Specialty (cardiology,  gastroenterology, etc)

Work in progress.... several additional entries will be
added in the coming months....
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[Alternative Section: All new drugs listed in alphabetical order ]led

[  Analgesics /  Pain Mgmt  / Pain syndromes  ]  top of page icon

Caldolor™ (ibuprofen) Injection: Analgesia (Pain) - Caldolor is indicated in adults for the management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics. Antipyretic (Fever)-Caldolor is indicated for the reduction of fever in adults.
NUCYNTA® (tapentadol) tablets: NUCYNTA® is an opioid analgesic indicated for the relief of moderate to severe acute pain in patients 18 years of age or older.
Savella® (milnacipran HCl) Tablets: Savella is indicated for the management of fibromyalgia.

[  Cardiology  ]  top of page icon

ADEMPAS® ( riociguat)  [Pulmonary Hypertension]
BRILINTA™ (ticagrelor): Acute Coronary Syndromes: BRILINTA is a P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) (unstable angina, non-ST elevation myocardial infarction, or ST elevation myocardial infarction). BRILINTA has been shown to reduce the rate of a combined endpoint of cardiovascular death, myocardial infarction or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with PCI, it also reduces the rate of stent thrombosis.
BYSTOLIC® (nebivolol): BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension
Cleviprex ® (clevidipine): Cleviprex is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
EDARBI ® (azilsartan medoxomil) - Edarbi is an angiotensin II receptor blocker indicated for the treatment of hypertension
EFFIENT™ (prasugrel) tablets: Effient™ is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) .
KYNAMRO™ (mipomersen sodium): KYNAMRO™ is an oligonucleotide inhibitor of apolipoprotein B-100 synthesis indicated as an adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apo B), total cholesterol (TC), and non-high density lipoprotein-cholesterol (non HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH)
LIVALO® (pitavastatin) Tablet: LIVALO is a HMG-CoA reductase inhibitor indicated for: Patients with primary hyperlipidemia and mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C)
MULTAQ® (dronedarone) tablet:   MULTAQ® is indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter geq50 mm or left ventricular ejection fraction [LVEF] <40%), who are in sinus rhythm or who will be cardioverted  
PRADAXA® (dabigatran etexilate mesylate) : PRADAXA is a direct thrombin inhibitor indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation
Tekturna® (aliskiren): Tekturna is indicated for the treatment of hypertension. Tekturna may be used alone or in combination with other antihypertensive agents. Use with maximal doses of ACE inhibitors has not been adequately studied.
XARELTO ® (rivaroxaban): XARELTO is a factor Xa inhibitor indicated: (1) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. (2) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing knee or hip replacement surgery

[  Electrolytes  ]  top of page icon

SAMSCA™ (tolvaptan) tablets: SAMSCA™ is indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure, cirrhosis, and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).

[  Endocrinology  ]  top of page icon

TRADJENTA™ (linagliptin) tablet: TRADJENTA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
VICTOZA® (liraglutide injection) : Victoza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
INVOKANA™(canagliflozin) tablets, for oral use
KAZANO® (alogliptin and metformin hcl)
NESINA® (alogliptin) tablets

[  Gastroenterology  ]  top of page icon

ENTEREG® (alvimopan): ENTEREG is indicated to accelerate the time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis.
RELISTOR® (methylnaltrexone bromide): RELISTOR® is indicated for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond four months has not been studied.
SUPREP BOWEL PREP®: SUPREP Bowel Prep Kit is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.
 

[  Gynecology  ] top of page icon

ELLA (ulipristal acetate): Ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. ella is not intended for routine use as a contraceptive.

[  HEENT - ophthalmic etc ]  top of page icon

BEPREVE™ (bepotastine besilate ophthalmic solution): BEPREVE™ is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis.
Besivance™ (besifloxacin ophthalmic susp): is a quinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates  [INFECTIOUS DISEASE]
LASTACAFT ® (alcaftadine) solution/ drops: LASTACAFT® is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.
ZYMAXID™ (gatifloxacin ophthalmic solution) 0.5%: ZYMAXID™ ophthalmic solution is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group*, Streptococcus oralis*, Streptococcus pneumoniae

[  Infectious Disease /  HIV  /   Hepatitis  ] top of page icon

DIFICID™ (fidaxomicin) tablet, film coated:  DIFICID is a macrolide antibacterial drug indicated in adults (geq18 years of age) for treatment of Clostridium difficile-associated diarrhea 
DORIBAX® (doripenem) powder, for solution: Complicated Intra-Abdominal Infections. Complicated Urinary Tract Infections, Including Pyelonephritis.
EGRIFTA® (tesamorelin) kit : EGRIFTA® is a growth hormone releasing factor (GRF) analog indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
EDURANT™ (rilpivirine hydrochloride) tablet: EDURANT is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated: In combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve adult patients.
INCIVEK™ (telaprevir) tablet: INCIVEK is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated, in combination with peginterferon alfa and ribavirin, for the treatment of genotype 1 chronic hepatitis C (CHC) in adult patients with compensated liver disease, including cirrhosis, who are treatment-naïve or who have been previously treated with interferon-based treatment, including prior null responders, partial responders, and relapsers.
INTELENCE® (etravirine) [Tablets]: INTELENCE® is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated: In combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other antiretroviral agents. In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE® in combination with onlyN[t]RTIs.
ISENTRESS® (raltegravir) Tablets: ISENTRESS is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated: In combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients.
Natroba (spinosad) topical suspension, 0.9%: NATROBA Topical Suspension is a pediculicide indicated for the topical treatment of head lice infestations in patients four (4) years of age and older.
Selzentry™ (maraviroc) tablets: SELZENTRY, in combination with other antiretroviral agents, is indicated for adult patients infected with only CCR5-tropic HIV-1.
TEFLARO™ (ceftaroline fosamil) : Acute Bacterial Skin and Skin Structure Infections.  Community-Acquired Bacterial Pneumonia.
Ulesfia® (benzyl alcohol) Lotion: Ulesfia Lotion is a pediculicide indicated for the topical treatment of head lice infestation in patients 6 months of age and older.
VIBATIV (telavancin HCL) injection®: VIBATIV is indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms ....
VICTRELIS™ (boceprevir) : VICTRELIS™ (boceprevir) is indicated for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.

[  Nephrology  ] top of page icon

Feraheme® (ferumoxytol) Injection: Feraheme is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD).
Phoslyra® (calcium acetate oral solution): PHOSLYRA is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease.

[  Neurology  ] top of page icon

AMPYRA™ (dalfampridine) is a potassium channel blocker indicated to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed
APTIOM® (eslicarbazepine acetate) tablets  [See anticonvulsants]
BANZEL® (rufinamide): BANZEL (rufinamide) is an anti-epileptic drug indicated for: Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 4 years and older and adults.
GILENYA™ (fingolimod hcl): GILENYA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
HORIZANT® (gabapentin enacarbil) Extended-Release Tablets: HORIZANT is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults.
ONFI™ (clobazam): ONFI is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older
POTIGA™ (ezogabine): POTIGA is a potassium channel opener indicated as adjunctive treatment of partial-onset seizures in patients aged 18 years and older.
Sabril® (vigabatrin) Tablets: SABRIL® is indicated as adjunctive therapy for adult patients with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss.
VIMPAT® (lacosamide) : Partial-Onset Seizures: VIMPAT (lacosamide) tablets and oral solution are indicated as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older. VIMPAT (lacosamide) injection for intravenous use is indicated as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older when oral administration is temporarily not feasible.

[  Oncology / Hematology ] top of page icon

GILOTRIF™ (afatinib) tablets
HALAVEN ™ (eribulin mesylate) injection: HALAVEN is a microtubule inhibitor indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting
IMBRUVICA™ (ibrutinib) capsules
PROMACTA® (eltrombopag olamine) tablet: PROMACTA is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
ZYTIGA™ (abiraterone acetate): ZYTIGA in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who have received prior chemotherapy containing docetaxel.

[  Psychiatry  ] top of page icon

BRINTELLIX® (vortioxetine) tablets [See antidepressants]
FANAPT® (iloperidone) tablet: FANAPT is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults.
LATUDA (lurasidone hydrochloride) tablet, film coated: LATUDA is indicated for the treatment of patients with schizophrenia.
SAPHRIS® (asenapine) sublingual tablets: SAPHRIS is indicated for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder.
SUBOXONE ® (buprenorphine HCL and naloxone HCL) tablet: SUBOXONE and SUBUTEX are indicated for the treatment of opioid dependence.
VIIBRYD (vilazodone HCL) tablet: VIIBRYD is indicated for the treatment of major depressive disorder (MDD). The efficacy of VIIBRYD was established in two 8-week, randomized, double-blind, placebo-controlled trials in adult patients with a diagnosis of MDD.

[  Pulmonary  ] top of page icon

ANORO™ ELLIPTA™ (umeclidinium and vilanterol) [See pulmonary combo agents]
ARCAPTA™ NEOHALER (indacaterol maleate): ARCAPTA NEOHALER is a long-acting beta2-adrenergic agonist indicated for: The long term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
BREO™ ELLIPTA™ (fluticasone furoate and vilanterol inhalation powder)
DALIRESP™ (roflumilast) tablet: DALIRESP™ is 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.
DULERA® (mometasone furoate and formoterol fumarate): DULERA is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: Treatment of asthma in patients 12 years of age and older.
 

[  Rheumatology  ] top of page icon

ACTEMRA® (tocilizumab): Rheumatoid Arthritis (RA): ACTEMRA® (tocilizumab) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. Systemic Juvenile Idiopathic Arthritis (SJIA): ACTEMRA® (tocilizumab) is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older
BENLYSTA® (belimumab): BENLYSTA ® (belimumab) is indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.
KRYSTEXXA™ (pegloticase): KRYSTEXXA™ (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.
Prolia® (denosumab): Prolia is a RANK ligand (RANKL) inhibitor indicated for: Treatment of postmenopausal women with osteoporosis at high risk for fracture. Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
ULORIC® (febuxostat) tablet: ULORIC is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout.
XIAFLEX™ (collagenase clostridium histolyticum): XIAFLEX is indicated for the treatment of adult patients with Dupuytren’s contracture with a palpable cord.
 

[  Urology  ] top of page icon

RAPAFLO® (silodosin) capsules: RAPAFLO, an alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). RAPAFLO is not indicated for the treatment of hypertension.
Toviaz® (fesoterodine fumarate): Toviaz is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

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