Cinacalcet hydrochloride (Sensipar - Amgen) has been approved by the FDA for treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis and treatment of hypercalcemia in patients with parathyroid carcinoma.

An orally dissolving, immediate-release tablet formulation of carbidopa/levodopa (Parcopa - Schwarz) that can be taken without water is now available for treatment of Parkinson's disease.

A new albumin-bound formulation of paclitaxel (Abraxane - American Pharmaceutical Partners) has been approved by the FDA for treatment of metastatic breast cancer after failure of combination chemotherapy or relapse within 6 months of adjuvant chemotherapy. This formulation is free of polyoxyethylated castor oil (Cremophor), a solvent thought to contribute to the hypersensitivity reactions that occur frequently with standard paclitaxel (Taxol, and others) and are severe in about 3% of patients.

The American Heart Association (AHA) recently published a statement saying that it would be reasonable to obtain an electrocardiogram (ECG) in children being evaluated for stimulant drug therapy for attention deficit hyperactivity disorder (ADHD). A subsequent news release in conjunction with the American Academy of Pediatrics provided a clarification, saying that it would be reasonable to consider obtaining an ECG in such children.

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.