Rebetron, a combination of injected recombinant interferon alfa-2b with oral ribavirin has been approved by the FDA for treatment of chronic hepatitis C virus infection.

Entacapone (Comtan), a catechol-O-methyltransferase (COMT) inhibitor, has been approved by the FDA for adjunctive use with levodopa/carbidopa in patients with Parkinson's disease who have end-of-dose "wearing off"symptoms.

Fluoxetine, a selective serotonin reuptake inhibitor (SSRI) previously sold only as Prozac, is now also marketed as Sarafem for treatment of premenstrual dysphoric disorder (PMDD). Generic fluoxetine is expected to be available sometime this year.

The FDA had approved an intrauterine contraceptive device that releases the synthetic progestin levonorgestrel over a period of five years. The device has been available in Europe for 10 years.

Recombinant human granulocyte colony stimulating factor (G-CSF, filgrastim) conjugated to polyethylene glycol (pegfilgrastim, Neulasta - Amgen) has been approved by the FDA for use in neutropenic patients with non-myeloid malignancies who are at high risk for infection. Filgrastim (Neupogen - Amgen) has been available in the US since 1991.

A reader expressed disappointment that our recent listing of “Some Warfarin Drug Interactions”1 did not include acetaminophen. Perhaps it should have. Acetaminophen can increase the anticoagulant effect of warfarin, particularly with continued use, but it does so inconsistently. The mechanism of this interaction has not been established, but may be related to an acetaminophen metabolite inhibiting vitamin K-epoxide reductase, the target for warfarin’s anticoagulant effect.2Patient susceptibility varies, possibly on a genetic basis; occasional use of acetaminophen generally has little or...

Gabapentin enacarbil (Horizant – GlaxoSmithKline), a new extended-release (ER) tablet formulation of gabapentin, has been approved by the FDA for treatment of moderate-to-severe restless legs syndrome (RLS). The immediate-release (IR) formulation of gabapentin (Neurontin,and others), which is approved for treatment of epilepsy and postherpetic neuralgia, has been used for many years to treat RLS. Another ER tablet formulation of gabapentin (Gralise) has been approved by the FDA for treatment of postherpetic neuralgia.

The FDA has approved vismodegib (vis moe deg´ ib; Erivedge – Genentech), the first hedgehog (Hh) pathway inhibitor, for oral treatment of metastatic basal cell cancer, locally advanced basal cell carcinoma that has recurred after surgery, or locally advanced basal cell carcinoma in adults who are not candidates for surgery or radiation.

Icosapent ethyl (Vascepa [vas EE puh] – Amarin), the ethyl ester of eicosapentaenoic acid (EPA), has been approved by the FDA as an adjunct to diet for treatment of severe hypertriglyceridemia (≥500 mg/dL). Vascepa is the second omega-3 polyunsaturated fatty acid (PUFA) product to become available by prescription for this indication; Lovaza (formerly Omacor), which is a combination of the ethyl esters of EPA and docosahexaenoic acid (DHA), was the first. Many omega-3 PUFA-containing fish oil capsules are sold over the counter as dietary supplements.

The FDA has approved a once-daily, extended-release chewable tablet formulation of methylphenidate (QuilliChew ER – Pfizer) for treatment of attention-deficit/hyperactivity disorder (ADHD). It is the first long-acting chewable formulation of the drug to be marketed in the US. Immediate-release chewable methylphenidate tablets (Methylin, and generics) have been available since 2003.