A once-daily extended-release (ER) oral formulation of the opioid analgesic hydromorphone hydrochloride (Palladone - Purdue Pharma) has been approved by the FDA for treatment of opioid-tolerant patients with persistent moderate to severe pain. Hydromorphone HCl, a semisynthetic congener of morphine and active metabolite of hydrocodone that has been used since the 1920s, is also available in immediate-release oral, injectable and suppository forms (Dilaudid, and others).

Micafungin sodium (Mycamine - Astellas), the second echinocandin antifungal to become available in the US, has been approved by the FDA for intravenous treatment of esophageal candidiasis and prophylaxis of invasive Candida infections in patients undergoing hematopoietic stem cell transplantation (HSCT).

The Medical Letter reported last year that sildenafil (Viagra - Pfizer) appeared to be effective for idiopathic pulmonary arterial hypertension (PAH), but confirmation from a controlled trial was needed. Now the results of such a study are about to be published, and the drug has been approved by the FDA for this indication under the trade name Revatio.

The FDA has licensed Adacel (Aventis Pasteur) and Boostrix (GlaxoSmithKline), two new combination vaccines that include tetanus toxoid, diphtheria toxoid and acellular pertussis antigens (Tdap), for use as a booster in adolescents and adults. In the past, older children and adults were not re-immunized against pertussis because of concerns about reactions to the whole-cell vaccine previously used in younger children. The CDC Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) have recommended that either of the new Tdap vaccines replace routine...

A transdermal patch formulation of methylphenidate (Daytrana - Noven/Shire) has been approved by the FDA for treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥ 6 years old. Like other methylphenidate products, the patch is a schedule II controlled substance. According to the manufacturer, it will be available in pharmacies by the end of June.

Insulin detemir (Levemir - Novo Nordisk) is the second long-acting basal insulin analog to be marketed in the US for treatment of both type 1 and type 2 diabetes. Detemir differs from human insulin by the elimination of the amino acid threonine in position B30 and the addition of a 14-carbon fatty acid chain at position B29. Insulin glargine (Lantus), the first long-acting insulin analog, has been available since 2001 and is usually given once daily.1 NPH insulin is an intermediate-acting basal insulin given twice daily. Basal insulins are usually combined with prandial doses of a rapid-acting...

Nabilone, an oral synthetic cannabinoid similar to delta-9-tetrahydrocannabinol (THC), the active ingredient in marijuana, has recently been reintroduced to the US market (Cesamet - Valeant) after a 17-year absence. The previous manufacturer discontinued marketing of the drug for commercial reasons. Nabilone is classified as a Schedule II controlled substance.

Paliperidone (Invega - Janssen) has been approved by the FDA in an extended-release formulation for treatment of schizophrenia. It is the primary active metabolite of the second-generation antipsychotic risperidone (Risperdal - Janssen), which is scheduled to lose its patent exclusivity in December 2007.

MoviPrep (Salix) is a new polyethylene glycol (PEG)-based bowel cleansing preparation approved for use in adults prior to colonoscopy. It contains ascorbic acid, which acts as an additional cathartic and flavoring agent, and requires a lower volume of fluid (3 L compared to the traditional 4 L) than most other PEG products. HalfLytely is an FDA-approved 2-L PEG product, but it must be taken with bisacodyl.

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.