Evolocumab (Repatha – Amgen), a subcutaneously injected PCSK9 inhibitor, has been approved by the FDA 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 also approved as an adjunct to diet and other LDL-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C. Evolocumab is the second PCSK9 inhibitor to be approved in the...

The FDA has approved infliximab-dyyb (Inflectra – Pfizer; marketed as Remsima in some countries), as a biosimilar of the TNF inhibitor infliximab (Remicade). Infliximab-dyyb was approved in the European Union (EU) in 2013 and in Canada in 2014. It is the second biosimilar to be approved by the FDA. Filgastrim-sndz (Zarxio), a recombinant human granulocyte colony-stimulating factor, was the first.

Photoplex (Herbert), a new sunscreen formulation containing 7% padimate O and 3% Parsol 1789, is being advertised as the first and only chemical sunscreen with proven absorption throughout the UVB and UVA spectrum.

The gram-positive bacillus Clostridium difficile is the most common identifiable cause of antibiotic-associated diarrhea and pseudomembranous colitis (R Fekety in GL Mandell et al, eds, Principles and Practice of Infectious Diseases, 3rd ed, New York:Churchill Livingstone, 1990, page 863). C. difficile colitis usually develops during or soon after antibiotic treatment. Virtually any antimicrobial agent can cause the disorder, but clindamycin, ampicillin and the cephalosporins have been implicated most frequently. Pseudomembranous colitis was recently reported in five patients who had ...

Metipranolol hydrocholride 0.3% (OptiPranolol - Bausch & Lomb), a nonselective beta-adrenergic receptor blocking drug, was recently marketed of ophthalmic use to decrease intraolular pressure in ocular hypertension or chronic open-angle glaucoma. Beta-blockers available in the USA for treatment of glaucoma are listed in this article.

Recombinant human deoxyribonuclease I (rhDNase; dornase alfa; Pulmozyme - Genentech), an enzyme that hydrolyzes extracellular DNA, is now available as a purified solution to decrease the viscosity of sputum in patients with cystic fibrosis. It requires a nebulizer to produce an aerosol mist for inhalation.

The US Food and Drug Administration has approved use of the angiotensin-converting enzyme (ACE) inhibitor captopril (Capoten) for patients with left ventricular dysfunction after a myocardial infarction. ACE inhibitors, widely used for treatment of hypertension, in recent years have also been used for treatment of heart failure (Medical Letter, 35:40, 1993).

Valacyclovir (Valtrex - Glaxo Wellcome), an L- valyl ester of acyclovir (Zovirax), has been approved by the US Food and Drug Administration (FDA) for oral treatment of herpes zoster (shingles) in immunocompetent adults. Famciclovir (Famvir - Medical Letter, 36:97, 1994) is also available for this indication.

Sodium hyaluronate (Hyalgan - Sanofi) and hylan G-F 20 (Synvisc - Wyeth- Ayerst) have been approved by the FDA for intra-articular injections in patients with knee pain due to osteoarthritis. Hylan G-F 20 is a cross-linked derivative of hyaluronic acid with a higher molecular weight than sodium hyaluronate. 'Hyaluronan' refers to either the acid or its salt.

Tamoxifen, anti-estrogen used for many years in the treatment of breast cancer, has now been approved by the FDA for reducing the incidence of breast cancer in women at increased risk of developing the disease.