Ambrisentan (Letairis - Gilead), a selective endothelin type A (ET_A) receptor antagonist, has been approved by the FDA for treatment of symptomatic patients (WHO class II or III) with pulmonary arterial hypertension (PAH).

The FDA has approved the sGC stimulator riociguat (rye" oh sig' ue at; Adempas – Bayer) for oral treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) following surgery or when surgery is not an option. It is the first drug to be approved for treatment of CTEPH.

The FDA recently advised health care professionals and consumers not to use a number of dietary supplements found to contain the phosphodiesterase-5 inhibitor sildenafil (Viagra) or an analog of the drug (www.fda.gov). Although the effects of sildenafil may be noticeable (in men), the presence of other, possibly more toxic adulterants in dietary supplements may be more difficult or impossible to detect.Other drugs previously found in dietary supplements have included lovastatin (Mevacor, and others), estrogen, alprazolam (Xanax, and others), indomethacin (Indocin, and others) and warfarin...

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Alfuzosin hydrochloride (Uroxatral - Sanofi-Synthelabo) is now available in the US in a new formulation for once-daily treatment of benign prostatic hyperplasia (BPH). The drug has been used in Europe since 1987. Alpha₁-blockers cause relaxation of smooth muscle tone in the bladder neck, prostatic capsule and prostatic urethra, relieving symptoms of urinary obstruction.

Low-intensity extracorporeal shockwave therapy similar to that used to fragment kidney stones or gallstones is a new option for treatment of erectile dysfunction that is now being advertised extensively in the US. It has not been approved by the FDA for treatment of erectile dysfunction.

The FDA has authorized over-the-counter (OTC) sale of a nonmedicated alcohol-based gel (Eroxon – Futura) for treatment of erectile dysfunction (ED) in males ≥22 years old. Eroxon is the only FDA-approved OTC and topical treatment for erectile dysfunction. It is also available in the UK and the EU.

The FDA has approved a sublingual powder formulation of nitroglycerin (GoNitro – Espero) for prevention or acute relief of an attack of angina pectoris. It is the first powder formulation of nitroglycerin to become available in the US. Most patients with angina use sublingual nitroglycerin tablets (Nitrostat, and generics). Translingual spray formulations of nitroglycerin (NitroMist, Nitrolingual Pumpspray, and generics) are also available.

The FDA has approved the use of the phosphodiesterase-5 (PDE-5) inhibitor tadalafil (Cialis – Lilly) for treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in men with or without erectile dysfunction. Tadalafil is approved for use under another brand name (Adcirca) for treatment of pulmonary arterial hypertension. The other PDE-5 inhibitors available in the US for treatment of erectile dysfunction (sildenafil [Viagra]; vardenafil [Levitra]) have also been reported to be effective for treatment of BPH signs and symptoms, but have not been approved for this...

The FDA has approved an intranasal gel formulation of testosterone (Natesto – Trimel/Endo) for replacement therapy in men with hypogonadism. Packaged in a metered-dose pump, Natesto is the first intranasal testosterone to become available in the US. Like other testosterone products, it is classified as a schedule III controlled substance. The FDA recently cautioned against using testosterone to treat low testosterone levels solely due to aging because the benefits and safety of such use have not been established, and there is a possible increased risk of myocardial infarction...