The FDA has approved a transmucosal tablet formulation of fentanyl citrate (Fentora - Cephalon) for management of breakthrough pain in opioid-tolerant patients with cancer. An oral transmucosal fentanyl lozenge on a stick (Actiq, and others) is also available for this indication, and is widely used off-label for chronic, non-cancer pain as well.

Duloxetine (Cymbalta - Lilly) is the second drug to be approved by the FDA for treatment of fibromyalgia. Pregabalin (Lyrica), which is also approved for treatment of neuropathic pain and epilepsy, was the first. Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) that is already marketed for treatment of depression and diabetic neuropathy.

Pregabalin (Lyrica - Pfizer) is the first drug approved by the FDA for management of fibromyalgia. When it was first marketed, pregabalin, which is structurally similar to gabapentin (Neurontin, and others), was approved for treatment of neuropathic pain associated with postherpetic neuralgia and diabetic peripheral neuropathy and for adjunctive treatment of partial onset seizures in adults with epilepsy. It has also been prescribed off-label for other types of neuropathic pain such as sciatica.

The FDA has approved datopotamab deruxtecan (Datroway – Daiichi Sankyo/AstraZeneca), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of adults with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

Terbinafine (Lamisil - Sandoz), an allylamine synthetic antifungal, previously available in the USA in a topical formulation (Medical Letter, 35:76, 1993) has now been marketed for oral use in the treatment of fungal nail infections caused by dermatophytes. Oral terbinafine has been available in Europe since 1992.

Dirithromycin (Dynabac - manufactured by Lilly, distributed by Bock), an oral macrolide antibiotic chemically similar to erythromycin, clarithromycin (Biaxin) and azithromycin (Zithromax), has been approved for marketing by the US Food and Drug Administration (FDA).

Rifabutin (formerly ansamycin; Mycobutin - Adria), a rifamycin antibiotic similar to rifampin (Rifadin, Rimactane) was recently approved by the US Food and Drug Administration for prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.

Alosetron hydrochloride (Lotronex - Glaxo Welcome), a selective serotonin receptor antagonist, has received FDA approval for treatment of irritable bowel syndrome (IBS) in women whose primary bowel symptom is diarrhea.

Duetact (Takeda), a new fixed-dose combination of the thiazolidinedione pioglitazone (Actos) and the sulfonylurea glimepiride (Amaryl, and others), was recently approved by the FDA for treatment of type 2 diabetes. It is approved as an adjunct to diet and exercise to improve glycemic control in patients already taking pioglitazone and/or a sulfonylurea. Avandaryl, a combination of glimepiride and the thiazolidinedione rosiglitazone, was approved in 2006.

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).