The FDA has approved ticagrelor (Brilinta – AstraZeneca), an oral antiplatelet drug, for use with low-dose aspirin to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS). It will compete with clopidogrel (Plavix) and prasugrel (Effient) for such use. Clopidogrel is expected to become available generically in the US within the next few months.

The FDA has approved Onzetra Xsail (Avanir), a nasal powder formulation of sumatriptan, for acute treatment of migraine in adults. Nasal spray formulations of sumatriptan (Imitrex) and zolmitriptan (Zomig) have been available for many years.

Almotriptan (Axert - Pharmacia), and Frovatriptan (Frova - Elan) have been approved by the FDA for oral treatment of migraine headache (Drugs of Choice from The Medical Letter 2001, page 131.).

Tegaserod maleate (teg a ser' od; Zelnorm - Novartis), a serotonin derivative, has received FDA approval for short-term treatment of women with irritable bowel syndrome (IBS) whose primary symptom is constipation. Alosetron (Lotronex), which was withdrawn previously because of toxicity, will soon be available again for women with severe diarrhea-predominant IBS (Medical Letter 2002; 44:67).

Tadalafil (Cialis - Lilly Icos) is the third oral drug to be approved by the FDA for treatment of erectile dysfunction. It has a longer duration of action than sildenafil (Viagra) or vardenafil (Levitra - Medical Letter 2003; 45:77).

Two new formulations of existing drugs were recently approved by the FDA for treatment of male androgenetic alopecia. Finasteride, a steroid 5alpha-reductase inhibitor previously marketed in a 5-mg tablet as Proscar for treatment of benign prostatic hyperplasia (Medical Letter, 34:83, 1992), has now been approved in a 1-mg tablet as Propecia (Merck) for oral treatment of men with male pattern hair loss. Minoxidil, a peripheral vasodilator used to treat hypertension, was previously available over the counter in a 2% topical solution (Rogaine, and others) for treatment of androgenetic alopecia...

Several recent case reports suggest that oral sildenafil may be effective for treatment of pulmonary arterial hypertension (PAH). Sildenafil is currently marketed as Viagra for treatment of erectile dysfunction (Medical Letter 1998; 40:51).

Carnitine is a naturally occurring amino acid derivative essential for transport of long-chain fatty acids into mitochondria. It is advertised on the Internet as a dietary supplement that can promote weight loss, increase energy, enhance athletic performance and slow aging. Levocarnitine (Carnitor - Sigma-Tau) has been FDA approved for oral and parenteral treatment of primary carnitine deficiency since 1986. Products containing levocarnitine and its synthetic derivative acetyl-L-carnitine are available as dietary supplements in the US.

The FDA has approved an oral, fixed-dose combination (Treximet - GlaxoSmithKline) of the selective serotonin receptor agonist ("triptan") sumatriptan (Imitrex) and the nonsteroidal anti-inflammatory drug (NSAID) naproxen sodium (Anaprox, and others) for acute treatment of migraine attacks.

The FDA has approved cangrelor (Kengreal – The Medicines Company), an IV P2Y12 platelet inhibitor, as an adjunct to percutaneous coronary intervention (PCI) in patients who have not been pretreated with a P2Y12 inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.