New Generics
- Fentanyl citrate troche/lozenge (generic Actiq) transmucosal lollipop1,2
- Perindopril erbumine (generic Aceon) tablets3
New Drugs, Indications, Label Changes, and Dosage Forms
- Capsaicin 8% patch (Qutenza) has been approved by the U.S. Food and Drug Administration (FDA) as a prescription medication to treat pain associated with post-herpetic neuralgia.4 The patch is a higher concentration than over-the-counter (OTC) products. The most common side effects in clinical trials were pain, swelling, itching, redness, and bumps at the application site, as well as blood pressure increases.5 Patch placement requires the use of a topical anesthetic and additional pain relief (ice or opioid pain relievers). Therefore, patch placement must be performed by a healthcare professional. Once the patch is applied, the patient must be observed for at least an hour, as there could be a significant increase in blood pressure.
- Diclofenac sodium topical (Pennsaid) has been approved by the FDA as a topical treatment to manage knee osteoarthritis.6 The transdermal carrier dimethylsulfoxide (DMSO) is utilized to deliver active diclofenac sodium through the skin to the pain site.7
- Exenatide injection (Byetta) has been approved by the FDA as monotherapy for treating patients with Type 2 diabetes mellitus, along with diet and exercise.8
- Human papilloma virus (HPV) vaccine (Gardasil) has been approved by the FDA for preventing condyloma acuminata due to HPV types 6 and 11 in males ages 9 to 26.9 The makers hope that this vaccine will decrease the need to treat genital warts. Clinical studies showed that in males not infected with HPV at the beginning of the study, the vaccine was close to 90% effective in preventing genital warts caused by infection of HPV types 6 and 11. The manufacturer plans to obtain additional safety and effectiveness information in this patient population.
- Lansoprazole 24HR (Prevacid OTC) 15-mg delayed-release capsules are available for treating frequent heartburn.10 The capsules will be available by prescription in both the 15-mg and 30-mg dosage strengths.
- Metoclopramide HCl orally disintegrating tablet (Metozolv ODT) has been approved by the FDA for treating both acute and recurrent diabetic gastroparesis and for the short-term management (four to 12 weeks) of adults with documented symptomatic gastroesophageal reflux disease who do not respond to conventional therapy.11
- Peramivir intravenous will be made available by the Centers for Disease Control (CDC) as an emergency treatment for children and adult patients who develop H1N1 influenza and are nonresponsive to oral or inhaled antiviral therapies.12
- Rosuvastatin (Crestor) has been approved by the FDA for treating heterozygous familial cholesterolemia in children ages 10-17.13
- Telmisartan 80-mg tablets (Micardis) have been approved by the FDA for risk reduction of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years and older who are at high risk for major cardiovascular events, or who are not able to take angiotensin-converting enzyme inhibitors.14
- Telmisartan/amlodipine tablets (Twynsta) have been approved by the FDA as a new combination for treating hypertension, either alone or in combination with other antihypertensive agents. This combination is not indicated for cardiovascular risk reduction. The tablets are available in the following strengths of telmisartan/amlodipine, respectively: 40 mg/5 mg, 40 mg/10 mg, 80 mg/5 mg, and 80 mg/10 mg.
- Tranexamic acid (Lysteda) has been approved by the FDA for the treatment of menorrhagia.15 This is the first nonhormonal, oral therapeutic agent approved to treat this condition.16
Pipeline
- Indacaterol is being investigated as a once-daily bronchodilator for treating adults with chronic obstructive pulmonary disease (COPD).17 Novartis has received a complete response letter from the FDA requesting additional data on the dosing of the agent. The company is working with the FDA to resolve these issues.
- Rituximab injection (Rituxan) is approved for treating moderate to severe rheumatoid arthritis after patients have been treated with methotrexate, as well as non-Hodgkin’s lymphoma.18 Genentech/Biogen is attempting to expand rituximab use to treat patients earlier in the course of their disease. The FDA recently rejected this application, citing the rare but serious safety risk of developing progressive multifocal leukoencephalopathy.
