End of ’08 Drug Update

Market watch

First-time generics:

• Bupropion XL 300mg tablets (generic Wellbutrin XL 300mg)
• Eplerenone tablets (generic Inspra)
• Galantamine tablets (generic Razadyne)
• Mycophenolate Mofetil 250- and 500-mg tablets (generic CellCept)
• Nisoldipine ER tablets (generic Sular extended-release)
• Pamidronate 30-, 60- and 90-mg/mL injection (generic Aredia)
• Temazepam 7.5- and 22.5mg capsules (generic Restoril)

New Approvals

• Clevidipine butyrate (Cleviprex, The Medicines Company) is an intravenous (IV) calcium channel blocker. It is FDA approved for treatment of hypertension in patients who cannot take oral therapy or patients for whom oral therapy does not work. It is recommended that while patients receive clevidipine infusions they undergo continuous heart rate and blood pressure monitoring until their vital signs are stable. Patients should be monitored for the prospect of rebound hypertension (HTN).1
• Romiplostim (Nplate, Amgen) is FDA approved as the first agent to directly stimulate bone marrow to produce platelets in patients with chronic immune thrombocytopenic purpura (ITP). The FDA based its approval of romiplostim on two randomized clinical trials in patients who had at least one prior ITP treatment. The studies were six months in duration and included splenectomized and non-splenectomized patients. The FDA notes a risk evaluation and mitigation strategy has been developed to address risks associated with this agent, which will require all prescribers and patients to enroll in a special program to track the long-term safety of the drug.2
• Tetrabenazine (Xenazine, Prestwick Pharmaceuticals) is FDA approved for the treatment of chorea in Huntington’s disease (HD). Tetrabenazine is the first treatment of its kind approved in the United States for any HD symptom. The labeling contains a boxed warning regarding the appearance of serious side effects, including depression and suicidal thoughts and actions. The drug should not be used in patients who have untreated depression or who actively are suicidal. Concerns about the suicide risk are heightened in all HD patients. The medication decreases the amount of dopamine available to work at relevant brain synapses, which subsequently decreases involuntary movements. The most common side effects during clinical studies were depression, drowsiness, insomnia, nausea, and restlessness.3

New Indications and Dosage Forms

• Nicardipine hydrochloride 20 mg (HCl, Cardene IV, EKR Therapeutics) is FDA approved in single-dose IV bags as a pre-mixed 200 mL, ready-to-use injection. The pre-mixed bags contain either dextrose or sodium chloride.4
• Palonosetron hydrochloride (Aloxi, Eisai) is FDA approved for treating chemotherapy-induced nausea and vomiting, and is available as 0.5 mg oral capsules. It is indicated for the prevention of acute nausea and vomiting following initial and repeat courses of moderately emetogenic chemotherapy. A single dose (0.5 mg) is to be administered about one hour prior to beginning chemotherapy.5
• Tenofovir disoproxil fumarate (Viread, Gilead) is FDA approved for treating adults with chronic hepatitis B (HBV). The approval is based on data from a pair of doubleblind clinical trials in more than 400 patients and compared tenofovir disoproxil fumarate to adefovir dipivoxil (Hepsera, Gilead). A greater percentage of patients receiving tenofovir showed a complete response to treatment, compared to patients receiving adefovir. Tenofovir is a reverse transcriptase inhibitor, already FDA approved for use in combination with other antiretroviral agents for treating HIV.6
• Valsartan/hydrochlorothiazide tablets (Diovan HCT, Novartis) and valsartan/amlodipine tablets (Exforge, Novartis) have been FDA approved as first-line treatments of HTN in adults who are likely to need more than one drug.7