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Onexton Gel for Acne

   
The Medical Letter on Drugs and Therapeutics • Aug 31, 2015  (Issue 1476)
and the oxidizing agent benzoyl peroxide (Onexton Gel 1.2%/3.75% – Valeant) for topical treatment of acne ...
The FDA has approved another fixed combination of the antibiotic clindamycin phosphate and the oxidizing agent benzoyl peroxide (Onexton Gel 1.2%/3.75% – Valeant) for topical treatment of acne in patients ≥12 years old. Topical products containing the same drugs have been available for many years. Onexton Gel contains a new strength of benzoyl peroxide.
Med Lett Drugs Ther. 2015 Aug 31;57(1476):124 | Show Introduction Hide Introduction

Alirocumab (Praluent) to Lower LDL-Cholesterol

   
The Medical Letter on Drugs and Therapeutics • Aug 17, 2015  (Issue 1475)
of ≥50%, for patients with clinical atherosclerotic cardiovascular disease.1 The National Lipid ...
The FDA has approved the subcutaneously injected PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor alirocumab (Praluent – Sanofi/Regeneron) as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-cholesterol (LDL-C). It was not approved for general use in statin-intolerant patients. Alirocumab is the first PCSK9 inhibitor to be approved in the US. Evolocumab (Repatha – Amgen), another PCSK9 inhibitor, was...
Med Lett Drugs Ther. 2015 Aug 17;57(1475):113-5 | Show Introduction Hide Introduction

Brexpiprazole (Rexulti) for Schizophrenia and Depression

   
The Medical Letter on Drugs and Therapeutics • Aug 17, 2015  (Issue 1475)
when adherence is a problem.1 Table 1. Pharmacology Class Second-generation antipsychotic Mechanism ...
The FDA has approved the oral, once-daily, second-generation antipsychotic brexpiprazole (Rexulti – Otsuka/Lundbeck) for treatment of schizophrenia and as an adjunct to antidepressants for treatment of major depressive disorder (MDD). Aripiprazole (Abilify), a structurally similar second-generation antipsychotic also comarketed by Otsuka (with BMS), recently became available generically.
Med Lett Drugs Ther. 2015 Aug 17;57(1475):116-8 | Show Introduction Hide Introduction

Palbociclib (Ibrance) for Metastatic Breast Cancer

   
The Medical Letter on Drugs and Therapeutics • Aug 17, 2015  (Issue 1475)
Table 1. Pharmacology Class CDK 4 and 6 inhibitor Formulation 75, 100, 125 mg capsules Route Oral ...
Palbociclib (Ibrance – Pfizer), an oral cyclin-dependent kinase inhibitor, has been approved by the FDA for use in combination with the aromatase inhibitor letrozole (Femara, and generics) for first-line treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer. It is the first cyclin-dependent kinase inhibitor to become available in the US.
Med Lett Drugs Ther. 2015 Aug 17;57(1475):115-6 | Show Introduction Hide Introduction

Panobinostat (Farydak) for Multiple Myeloma (online only)

   
The Medical Letter on Drugs and Therapeutics • Aug 17, 2015  (Issue 1475)
(PANORAMA1) in 768 patients with relapsed or refractory multiple myeloma who had received 1-3 previous ...
The FDA has approved panobinostat (Farydak – Novartis), an oral histone deacetylase (HDAC) inhibitor, for use in combination with bortezomib (Velcade) and dexamethasone for treatment of patients with multiple myeloma who have received at least 2 prior therapies including bortezomib and an immunomodulatory drug. It is the first HDAC inhibitor to be approved for this indication.
Med Lett Drugs Ther. 2015 Aug 17;57(1475):e118-9 | Show Introduction Hide Introduction

Lenvatinib (Lenvima) for Thyroid Cancer (online only)

   
The Medical Letter on Drugs and Therapeutics • Aug 17, 2015  (Issue 1475)
inhibitor and in those who had not (median progression-free survival 15.1 and 18.7 months, respectively ...
The FDA has approved the oral multikinase inhibitor lenvatinib (Lenvima – Eisai) for treatment of locally recurrent or metastatic, progressive, differentiated thyroid cancer (papillary or follicular) refractory to radioactive iodine treatment.
Med Lett Drugs Ther. 2015 Aug 17;57(1475):e120-1 | Show Introduction Hide Introduction

Rifaximin (Xifaxan) for Irritable Bowel Syndrome with Diarrhea

   
The Medical Letter on Drugs and Therapeutics • Aug 03, 2015  (Issue 1474)
that has not responded to fiber and laxatives.1,2 MECHANISM OF ACTION — Rifaximin is a minimally absorbed, broad ...
Rifaximin (Xifaxan – Salix), a minimally absorbed oral antibiotic approved previously to treat travelers' diarrhea and to reduce the risk of recurrent hepatic encephalopathy, has now been approved by the FDA for treatment of irritable bowel syndrome with diarrhea (IBS-D). Eluxadoline (Viberzi – Actavis), a mu-opioid receptor agonist, was also recently approved for IBS-D and will be reviewed in a future issue.
Med Lett Drugs Ther. 2015 Aug 3;57(1474):109-11 | Show Introduction Hide Introduction

In Brief: Duopa - A Carbidopa/Levodopa Enteral Suspension for Parkinson's Disease

   
The Medical Letter on Drugs and Therapeutics • Aug 03, 2015  (Issue 1474)
hours with immediaterelease tablets.1 Duopa is available in a 100-mL single-use cassette containing ...
The FDA has approved Duopa (Abbvie), a carbidopa/levodopa enteral suspension, for treatment of motor fluctuations in patients with advanced Parkinson's disease (PD). It has been available in Europe since 2001.In patients with advanced PD, emptying of the stomach may be delayed and unpredictable, which can affect the rate and amount of absorption of carbidopa/levodopa and its efficacy. To bypass the stomach, the new formulation is delivered through a nasojejunal (NJ) tube or percutaneous endoscopic gastrostomy with jejunal (PEG-J) tube.A randomized, double-blind, active-controlled, 12-week...
Med Lett Drugs Ther. 2015 Aug 3;57(1474):112 | Show Introduction Hide Introduction

Sacubitril/Valsartan (Entresto) for Heart Failure

   
The Medical Letter on Drugs and Therapeutics • Aug 03, 2015  (Issue 1474)
for patients who cannot tolerate an ACE inhibitor.1 MECHANISM OF ACTION — Neprilysin is a neutral ...
The FDA has approved Entresto (Novartis), an oral fixed-dose combination of the neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB) valsartan, to reduce the risk of cardiovascular death and heart failure hospitalization in patients with heart failure with reduced ejection fraction. Sacubitril is the first neprilysin inhibitor to become available in the US.
Med Lett Drugs Ther. 2015 Aug 3;57(1474):107-9 | Show Introduction Hide Introduction

Polidocanol (Varithena) for Varicose Veins

   
The Medical Letter on Drugs and Therapeutics • Aug 03, 2015  (Issue 1474)
and stripping.1 A meta-analysis of 13 randomized controlled trials in ˃3000 patients with great saphenous ...
An injectable foam formulation of the sclerosing agent polidocanol (Varithena – Provensis/BTG) has been approved by the FDA for treatment of incompetent veins and visible varicosities of the great saphenous vein system. It is the first foam therapy to be approved for this indication, but polidocanol and other sclerosants have been used for years as foam formulations compounded by physicians. Polidocanol is also available in a liquid formulation (Asclera) to treat smaller veins. Sodium tetradecyl sulfate (Sotradecol) is FDA-approved in a liquid formulation for use in...
Med Lett Drugs Ther. 2015 Aug 3;57(1474):111-2 | Show Introduction Hide Introduction