- 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
- 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.
Use of omeprazole and clopidogrel combination therapy should be avoided, according to new data from the FDA.18 Current data suggest that clopidogrel’s antiplatelet effect may be hindered by 50% with concomitant omeprazole therapy. Omeprazole blocks the conversion of clopidogrel to its active, antiplatelet form, thus significantly decreasing its effectiveness. It is not known if other proton-pump inhibitors interfere with clopidogrel’s effectiveness. Other drugs that should not be used with clopidogrel include esomeprazole (Nexium), cimetidine (Tagamet and Tagamet HB), fluconazole (Diflucan), ketoconazole (Nizoral), voriconazole (VFEND), etravirine (Intelence), felbamate (Felbatol), fluoxetine (Prozac, Sarafem, and Symbyax), fluvoxamine (Luvox), and ticlopidine (Ticlid). TH
Michele B. Kaufman is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.
- Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA Web site. Available at: www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=077312&TABLE1=OB_Rx. Accessed Nov. 19, 2009.
- Covidien gets approval of generic pain drug. Forbes.com Web site. Available at: http://www.forbes.com/feeds/ap/2009/10/30/business-health-care-us-covidien-actiq_7069457.html. Accessed Nov. 19, 2009.
- Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA Web site. Available at: www.accessdata.fda.gov/scripts/cder/ob/default.cfm Accessed Nov. 19, 2009.
- Riley K. FDA Approves New Drug Treatment for Long-Term Pain Relief after Shingles Attacks. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191003.htm. Accessed Nov. 19, 2009.
- Qutenza Approved for Post-Shingles Nerve Pain. U.S. News and World Report Web site. Available at: health.usnews.com/articles/health/healthday/2009/11/17/qutenza-approved-for-post-shingles-nerve-pain.html. Accessed Nov. 19, 2009.
- Nuvo shares surge on FDA pain cream approval. Reuters Web site. Available at: www.reuters.com/article/email/idUSN0543459820091105. Accessed Nov. 19, 2009.
- Pennsaid. Nuvo Web site. Available at: www.nuvoresearch.com/pipeline/pennsaid.asp. Accessed Nov. 19, 2009.
- BYETTA Approved For Expanded Use As First-Line Treatment For Type 2 Diabetes. Medical News Today Web site. Available at: www.medicalnewstoday.com/articles/169396.php. Accessed Nov. 19, 2009.
- Burgess S. FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys. FDA Web site. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm Accessed Nov. 19, 2009.
- Prevacid 24hr available over-the-counter. Monthly Prescribing Reference Web site. Available at: www.empr.com/prevacid-24hr-available-over-the-counter/article/157592/. Accessed Nov. 19, 2009.
- FDA Approves New Salix Product Exclusively in Catalent’s Zydis Fast Dissolve Technology. Catalent Web site. Available at: www.catalent.com/about-us/news/45. Accessed Nov. 19, 2009.
- Peramivir to be Used for Special Swine Flu Cases. Pharmaceutical-Technology.com Web site. Available at: www.pharmaceutical-technology.com/News/News68102.html. Accessed Nov. 19, 2009.
- Dennis M. AstraZeneca’s Crestor approved in US for paediatric use; Vimovo filed in Europe. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=41E54BF434C54C8E903A9EB4EF0839AA&logRowId=332380. Accessed Nov. 19, 2009.
- FDA Approves New Use for Micardis in Cardiovascular Risk Reduction and Twynsta as New Combination Treatment for High Blood Pressure. Boehringer Ingelheim Web site. Available at: us.boehringer-ingelheim.com/newsroom/2009/files/micardis_twynsta_approve_10-19-09.pdf. Accessed Nov. 19, 2009.
- Todoruk M. FDA approves Xanodyne’s Lysteda for menorrhaegia. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=8FCB424A8E7147A08CEC9BFCD8A450D2&logRowId=337054. Accessed Nov. 19, 2009.
- Xanodyne announces FDA approval of Lysteda for treatment of women with heavy menstrual bleeding. Xanodyne Web site. Available at: www.xanodyne.com/newsroom_details.asp?NewsId=61. Accessed Nov. 19, 2009.
- Todoruk M. FDA requests additional data for Novartis’ COPD drug indacaterol. FirstWord Web site. Available at: www.firstwordplus.com/Fws.do?articleid=B426F5ED30AB43A89338DAD0124168A7&logRowId=332718. Accessed Nov. 19, 2009.
- Genentech and Biogen Idec Receive a Complete Response from FDA for Earlier Use of Rituxan for Rheumatoid Arthritis. Genentech Web site. Available at: www.gene.com/gene/news/press-releases/display.do?method=detail&id=12407. Accessed Nov. 19, 2009.
- Walsh S. FDA Announces New Warning on Plavix: Avoid Use with Prilosec/Prilosec OTC. FDA Web site. Available at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191169.htm. Accessed Nov. 19, 2009.