Inhaled drugs for asthma are available in the US mainly in pressurized metered-dose inhalers (MDIs), which require a propellant, and dry powder inhalers, which do not. The chlorofluorocarbon (CFC) propellants in MDIs are being replaced by hydrofluoroalkane (HFA) propellants for environmental reasons: CFCs contribute to the depletion of the ozone layer. December 31, 2008 will be the last day that albuterol MDIs using CFC propellants can be sold in the US. The FDA is expected to announce a termination date for other CFC-containing products in the near future.Three HFA albuterol inhalers and one...

The FDA has approved Duexis (Horizon), a fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen and the H2-receptor antagonist (H2RA) famotidine, for symptomatic relief of osteoarthritis and rheumatoid arthritis and to decrease the risk of developing gastric and duodenal ulcers in patients at risk for NSAID-associated ulcers. Vimovo, a combination of the NSAID naproxen and the proton pump inhibitor (PPI) esomeprazole, is also approved by the FDA for prevention of NSAID-associated gastric ulcers.

Sildenafil (Viagra), tadalafil (Cialis) and vardenafil (Levitra, Staxyn) have become the standard treatment for erectile dysfunction. Head-to-head comparisons of these agents are still lacking, but some differences between them and new recommendations for their dosing (see Table 2) are worth noting.

The FDA has approved use of lubiprostone (Amitiza) for treatment of opioid-induced constipation in adults with chronic non-cancer pain. The drug was previously approved for chronic idiopathic constipation and irritable bowel syndrome with constipation.

The FDA has approved afatinib (Gilotrif — Boehringer Ingelheim), an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. These mutations occur in about 10% of patients with NSCLC. Afatinib is the second EGFR inhibitor to be approved for first-line treatment of advanced lung cancer. The first was erlotinib (Tarceva), which is also approved for treatment of patients with locally advanced...

The FDA has approved talimogene laherparepvec (Imlygic – Amgen), a genetically modified herpes simplex virus, for intralesional treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma that has recurred following surgery. It is the first oncolytic virotherapy to become available in the US.

The FDA has approved ferric pyrophosphate citrate solution (Triferic – Rockwell Medical) to maintain hemoglobin concentrations in adults with hemodialysis-dependent chronic kidney disease. Triferic is the first iron replacement product that is added into the hemodialysis solution at each dialysis procedure.

View the Comparison Table: Some Systemic Fluoroquinolones (online only)

The B-lymphocyte stimulator (BLyS)-specific inhibitor belimumab (Benlysta – GSK), which was approved earlier for treatment of active, autoantibody-positive, nonrenal, systemic lupus erythematosus (SLE), has now been approved for use in addition to standard therapy for treatment of active lupus nephritis in adults. Belimumab is the first drug to be approved in the US for treatment of both SLE and lupus nephritis.

Odevixibat (Bylvay – Albireo), an oral ileal bile acid transporter (IBAT) inhibitor, has been approved by the FDA for treatment of pruritus in patients ≥3 months old with progressive familial intrahepatic cholestasis (PFIC). It is the first drug to be approved in the US for this indication.