Retapamulin (re-tap'-a-mue'-lin; Altabax - Glaxo SmithKline) is a topical antibiotic recently approved by the FDA for treatment of bullous and non-bullous impetigo due to Streptococcus pyogenes and methicillin-susceptible Staphylococcus aureus. It is available as a 1% ointment by prescription only.

The FDA has approved a 1% cream formulation of ozenoxacin (Xepi – Cutanea), a nonfluorinated quinolone antibiotic, for treatment of impetigo caused by Staphylococcus aureus or Streptococcus pyogenes in patients ≥2 months old.

Lefamulin (Xenleta – Nabriva), a semisynthetic pleuromutilin antibiotic, has been approved by the FDA for IV and oral treatment of community-acquired bacterial pneumonia (CABP) in adults. It is the first systemic pleuromutilin antibiotic to be approved in the US; retapamulin (Altabax), a 1% topical ointment for treatment of impetigo, was approved in 2007.

Eculizumab (Soliris - Alexion) has been approved by the FDA for reduction of hemolysis in patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare form of hemolytic anemia. A recombinant humanized monoclonal antibody, eculizumab is the first drug to be marketed for this indication.

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 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.