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The mineral zinc is essential for the prevention of prostate problems.   |    Garlic is a popular herbal remedy which is best known for its treatment of coughs and colds.   |    Carrot are filled with natural enzymes and beta carotene,which can help the body resist diseases such as cancer and cardiovascular diseases.   |    Good habits create good thinkers.   |    Ginger is good for a calming,warming effect on the body and its superb for the relief of travel and morning sickness.   |    Sometimes your body needs a complete break from solid foods,Choose a suitable weekday or perhaps a weekend and drink a large glass of fresh juice every two hours.You'll clear poisons and wastes from your body and feel fabulously invigorated.   |    Good health and well being are all about making small changes to your diet,attitude and daily routine and practising them untilthey become habits.   |    Music can bring calm and peacefullness to anxious moments.   |    Poor posture can create all sorts of neck and back problems,so follow the good posture and make it a habit.   |    Green barley powder used to fight the growth of cancer cells, Add half teaspoon to half a glass of juice every day   |   

New Approvals (Last 50 drugs approved)

No Drug Indication Date Country Brand Company
1983 RALTEGRAVIR (New dosage form) 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 patients 4 weeks of age and older (1). The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response 20 December 2013 US ISENTRESS MERCK SHARP DOHME
1982 TREPROSTINIL DIETHANOLAMINE (New dosage form) a prostacyclin vasodilator indicated for: ? Treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. The study that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (75%) or PAH associated with connective tissue disease (19%). As the sole vasodilator, the effect on exercise is small. Orenitram has not been shown to add to other vasodilator therapy 20 December 2013 US TREPROSTINIL DIETHANOLAMINE UNITED THERAP
1981 SAPROPTERIN DIHYDROCHLORIDE (New dosage form) Kuvan is a phenylalanine hydroxylase activator indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Kuvan is to be used in conjunction with a Phe-restricted diet. 19 December 2013 US KUVAN BIOMARIN PHARM
1980 EPINEPHRINE (Drug already marketed without an approved NDA Adrenalin? is a non-selective alpha and beta adrenergic agonist indicated for: ? Emergency treatment of allergic reactions (Type 1), including anaphylaxis (Adrenalin? 1 mL and 30 mL vials) ? Induction and maintenance of mydriasis during intraocular surgery (Adrenalin? 1 mL vial only) 18 December 2013 US ADRENALIN JHP PHARMS
1979 UMECLIDINIUM; VILANTEROL (New molecular entity) ANORO ELLIPTA is a combination of umeclidinium, an anticholinergic, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). (1) Important limitations: Not indicated for the relief of acute bronchospasm or for the treatment of asthma. 18 December 2013 US ANORO ELLIPTA GLAXO GRP LTD
1978 SOFOSBUVIR (New molecular entity) SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. ? SOVALDI efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection. 06 December 2013 US SOVALDI GILEAD SCIENCES INC
1977 POSACONAZOLE (New dosage form) Noxafil is an azole antifungal agent indicated for: Delayed-release tablets and oral suspension ? prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised, such as HSCT recipients with GVHD or those with hematologic malignancies with prolonged neutropenia from chemotherapy. Oral suspension ? treatment of oropharyngeal candidiasis (OPC), including OPC re 25 November 2013 US NOXAFIL MERCK SHARP DOHME
1976 SIMEPREVIR (New molecular entity) OLYSIO is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. ? OLYSIO efficacy has been established in combination with peginterferon alfa and ribavirin in HCV genotype 1 infected subjects with compensated liver disease (including cirrhosis). ? OLYSIO must not be used as monotherapy. ? Screening patients with HCV genotype 1a infection for the presence of virus wi 22 November 2013 US OLYSIO JANSSEN RES AND DEV
1975 LULICONAZOLE (New molecular entity) LUZU (luliconazole) Cream, 1% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients 18 years of age and older. 14 November 2013 US LUZU MEDICIS
1974 IBRUTINIB (New molecular entity) IMBRUVICA is a kinase inhibitor indicated for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy . This indication is based on overall response rate. An improvement in survival or disease-related symptoms has not been established 13 November 2013 US IMBRUVICA PHARMACYCLICS INC
1973 ESLICARBAZEPINE ACETATE (New molecular entity) APTIOM is indicated as adjunctive treatment of partial-onset seizures. 08 November 2013 US APTIOM SUNOVION PHARMS INC
1972 OBINUTUZUMAB GAZYVA (obinutuzumab) is a CD20-directed cytolytic antibody and is indicated, in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia. 01 November 2013 US GAZYVA GENENTECH
1971 FLUTEMETAMOL F-18 (New molecular entity) Vizamyl is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate ?amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. A negative Vizamyl scan indicates s parse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impai 25 October 2013 US VIZAMYL GE HEALTHCARE
1970 HYDROCODONE BITARTRATE (New dosage form) For opioid-na?ve and opioid non-tolerant patients, initiate with 10 mg capsules orally every 12 h. ? To convert to Zohydro ER from another opioid, use available conversion factors to obtain estimated dose. ? Increase the dose of Zohydro ER in increments of 10 mg every 12 hours every 3 to 7 days as needed to achieve adequate analgesia. ? Individualize treatment; titrate to effective and tolerable dose. ? Capsules must be swallowed whole and are not to be chewed, crushed or dissolved. 25 October 2013 US ZOHYDRO ER ZOGENIX INC
1969 ECONAZOLE NITRATE (New dosage form) 1% AEROSOL, TOPICAL FOAM; Ecoza is an azole antifungal indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older. 24 October 2013 US ECOZA AMDERMA PHARMS
1968 TOCILIZUMAB ACTEMRA? (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) ? Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease- Modifying Anti-Rheumatic Drugs (DMARDs). Polyarticular Juvenile Idiopathic Arthritis (PJIA). ? Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis. Systemic Juvenile Idiopathic Arthritis (SJIA). ? Patient 21 October 2013 US ACTEMRA GENENTECH
1967 DICLOFENAC (New dosage form) ZORVOLEX 18 mg and 35 mg capsules, NSAID indicated for treatment of mild to moderate acute pain in adults. 18 October 2013 US ZORVOLEX IROKO PHARMS LLC
1966 MACITENTAN (New molecular entity) OPSUMIT is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). OPSUMIT also reduced hospitalization for PAH. 18 October 2013 US OPSUMIT ACTELION PHARMS LTD
1965 RIOCIGUAT (New molecular entity) Adempas is a soluble guanylate cyclase (sGC) stimulator indicated for the treatment of adults with: ? Persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class. ? Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class and to delay clinical worsening. 08 October 2013 US ADEMPAS BAYER HLTHCARE
1964 SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE (New dosage form) Indicated for cleansing of the colon in preparation for colonoscopy Administer in a split dose (2-day regimen) for a total volume of 96 oz (2880 mL) 04 October 2013 US BC GATOR PHARMA INC
1963 BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED (New combination) DUAVEE is a combination of conjugated estrogens with an estrogen agonist/antagonist indicated for treatment of the following conditions in women with a uterus: ? Treatment of moderate to severe vasomotor symptoms associated with menopause. ? Prevention of postmenopausal osteoporosis. Limitation of Use: DUAVEE should be used for the shortest duration consistent with treatment goals and risks for the individual woman. 03 October 2013 US DUAVEE WYETH PHARMS PFIZER
1962 VORTIOXETINE HYDROBROMIDE (New molecular entity) BRINTELLIX is .indicated for the treatment of major depressive disorder (MDD) 30 September 2013 US BRINTELLIX TAKEDA PHARMS USA
1961 BRIMONIDINE TARTRATE (New dosage form) MIRVASO (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older. 23 August 2013 US MIRVASO GALDERMA LABS LP
1960 TOPIRAMATE (New dosage form) Trokendi XR? is an antiepileptic drug indicated for: ?Partial Onset Seizure and Primary Generalized Tonic-Clonic Seizures -initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures and adjunctive therapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures. ?Lennox-Gastaut Syndrome (LGS) - adjunctive therapy in patients 6 years of age and older with seizures associated with Lennox-Gas 16 August 2013 US TROKENDI XR SUPERNUS PHARMS
1959 ENALAPRIL MALEATE (New dosage form) 1 mg/ml oral solution, Indicated for: ? treatment of hypertension in adults and children older than one month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 13 August 2013 US EPANED KIT SILVERGATE PHARMS
1958 DOLUTEGRAVIR SODIUM (New molecular entity) TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and children aged 12 years and older and weighing at least 40 kg. 12 August 2013 US TIVICAY VIIV HLTHCARE
1957 ESOMEPRAZOLE STRONTIUM (New active ingredient) Esomeprazole strontium is a proton pump inhibitor indicated for adults for: ? Treatment of gastroesophageal reflux disease (GERD) (1.1) ? Risk reduction of NSAID-associated gastric ulcer (1.2) ? H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3) ? Pathological hypersecretory conditions, including Zollinger-Ellison syndrome. 06 August 2013 US ESOMEPRAZOLE STRONTIUM HANMI PHARM CO LTD
1956 LEVOMILNACIPRAN HYDROCHLORIDE (New active ingredient) FETZIMA is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD). Limitation of Use: FETZIMA is not approved for the management of fibromyalgia. The efficacy and safety of FETZIMA for the management of fibromyalgia have not been established. 25 July 2013 US FETZIMA FOREST LABS INC
1955 TACROLIMUS (New dosage form) ASTAGRAF XL is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction. Limitations of use: ? Not interchangeable with tacrolimus immediate-release capsules ? Do not use simultaneously with cyclosporine 19 July 2013 US ASTAGRAF XL ASTELLAS
1954 GOLIMUMAB SIMPONI ARIA 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. 18 July 2013 US SIMPONI ARIA JANSSEN BIOTECH
1953 AFATINIB DIMALEATE (New molecular entity) GILOTRIF is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21. (L858R) substitution mutations as detected by an FDA-approved test (1) Limitation of Use: Safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations. 17 July 2013 US GILOTRIF BOEHRINGER INGELHEIM
1952 PAROXETINE MESYLATE (New dosage form) BRISDELLE is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause (VMS). Limitation of Use: BRISDELLE is not indicated for the treatment of any psychiatric condition. 28 June 2013 US BRISDELLE NOVEN THERAP
1951 TELAVANCIN VIBATIV is a lipoglycopeptide antibacterial drug indicated for the treatment of the following infections in adult patients caused by designated susceptible bacteria: ? Complicated skin and skin structure infections (cSSSI) ? Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus. VIBATIV should be reserved for use when alternative treatments are not suitable. 21 June 2013 US VIBATIV THERAVANCE INC
1950 OMEPRAZOLE; SODIUM BICARBONATE (OTC (over-the-counter) switch) Treatment of frequent heart burn ( 2 or more days a week) Not intended for immediate effect may take 1 to 4 days for full effect. 17 June 2013 US ZEGERID OTC MSD CONSUMER
1949 TRAMETINIB DIMETHYL SULFOXIDE (New molecular entity) MEKINIST is a kinase inhibitor indicated as a single agent and in combination with dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. The use in combination is based on the demonstration of durable response rate. Improvement in disease-related symptoms or overall survival has not been demonstrated for MEKINIST in combination with dabrafenib. Limitation of use: MEKINIST as a single agent is 29 May 2013 US MEKINIST GLAXOSMITHKLINE LLC
1948 DABRAFENIB MESYLATE (New molecular entity) TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. ? TAFINLAR in combination with trametinib is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. The use in combination is based on the demonstration of durable response rate. Improvement in disease-r 29 May 2013 US TAFINLAR GLAXOSMITHKLINE
1947 RADIUM RA-223 DICHLORIDE (New molecular entity) Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. 15 May 2013 US XOFIGO BAYER HLTHCARE
1946 FLUTICASONE FUROATE; VILANTEROL TRIFENATATE (New molecular entity) BREO ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS), and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for long-term, once-daily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Important limitations: Not indicated for relief of acute bronchospasm or for treatment of asthma. 10 May 2013 US BREO ELLIPTA GLAXO GRP LTD
1945 NIMODIPINE (New dosage form) NYMALIZE is a dihydropyridine calcium channel blocker indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V). 10 May 2013 US NYMALIZE ARBOR PHARMS INC
1944 ATORVASTATIN CALCIUM; EZETIMIBE (New combination) LIPTRUZET, which contains a cholesterol absorption inhibitor and an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet to: ? reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. ? reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments. Limita 03 May 2013 US LIPTRUZET MERCK SHARP DOHME
1943 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE (New dosage form) an estrogen/progestin combination oral contraceptive indicated for use by women to prevent pregnancy ? The efficacy in women with a body mass index of more than 35 kg/m2 has not been evaluated 19 April 2013 US NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE WARNER CHILCOTT
1942 BRIMONIDINE TARTRATE; BRINZOLAMIDE (New combination) a fixed combination of a carbonic anhydrase inhibitor and an alpha 2 adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. 19 April 2013 US SIMBRINZA ALCON RES LTD
1941 ACYCLOVIR (New dosage form) SITAVIG is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults. 12 April 2013 US SITAVIG BIOALLIANCE PHARMA
1940 DESOXIMETASONE (New dosage form) Topical Spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older. 11 April 2013 US TOPICORT TARO
1939 CANAGLIFLOZIN (New molecular entity) INVOKANA is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitation of Use: ? Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis 29 March 2013 US INVOKANA JANSSEN PHARMS
1938 CARBINOXAMINE MALEATE (New dosage form) Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension is an H1 receptor antagonist indicated for the symptomatic treatment of: ? Seasonal and perennial allergic rhinitis ? Vasomotor rhinitis ? Allergic conjunctivitis due to inhalant allergens and foods ? Mild, uncomplicated allergic skin manifestations of urticaria and angioedema ? Dermatographism ? As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have 28 March 2013 US KARBINAL ER TRIS PHARMA INC
1937 DIMETHYL FUMARATE (New molecular entity) TECFIDERA is indicated for the treatment of patients with relapsing forms of multiple sclerosis 27 March 2013 US TECFIDERA BIOGEN IDEC INC
1936 RABEPRAZOLE SODIUM (New dosage form) Delayed-Release Capsules, indicated in adults for: ? Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) ? Maintenance of Healing of Erosive or Ulcerative GERD ? Treatment of Symptomatic GERD ? Healing of Duodenal Ulcers ? Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence ? Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome In adolescent patients 12 years of age and older for: ? Short-term treatment 26 March 2013 US ACIPHEX SPRINKLE EISAI INC
1935 TOBRAMYCIN (New dosage form) 28 mg powder for inhalation, indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. 22 March 2013 US TOBI PODHALER NOVARTIS
1934 PHENYLEPHRINE HYDROCHLORIDE (Drug already marketed without an approved NDA) Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil 21 March 2013 US PHENYLEPHRINE HYDROCHLORIDE PARAGON BIOTECK
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