- Tamsulosin (generic Flomax) capsules should be available March 2, 20101
New Drugs, Indications, Dosage Forms, and Approvals
- C1 Esterase inhibitor [human] (Berinert) has been approved by the Food and Drug Administration (FDA) to treat acute abdominal attacks and facial edema associated with hereditary angioedema (HAE) in adolescents and adults. It is derived from human plasma and regulates clotting and inflammatory reactions. HAE, a genetic disorder affecting 6,000 to 10,000 Americans, is caused by a deficit of C1-INH.2
- Colesevelam HCl tablets (Welchol) have been approved by the FDA as an adjunct to diet and exercise for reducing LDL-C levels in boys and postmenarchal girls ages 10 to 17, with heterozygous familial hypercholesterolemia as monotherapy, or in combination with a statin after failing an adequate trial of diet therapy.3
- Colesevelam HCl (Welchol) has been approved by the FDA as an oral solution providing an alternate dosage form to the large oral tablets currently available.3
- Oxycodone HCl has been recommended for FDA approval. When this new formulation is dissolved in water, it forms a gel, which makes it difficult to abuse. If approved, the new formulation will keep the OxyContin name and will be available in seven dosages. The older product will be phased out and only the newer product will be available.4
- Peginterferon alpha-2b injection (PegIntron) has been recommended for FDA approval for the treatment of patients with stage-III malignant melanoma. Peginterferon alpha-2b currently is approved for treating hepatitis C in combination with ribavirin. It is a once-weekly, subcutaneous injection.5
- Ustekinumab (Stelara) has been approved by the FDA for treating moderate to severe plaque psoriasis by disabling two interleukin (IL) cytokines, IL-12 and IL-23.6 It is a monoclonal antibody administered via subcutaneous injection. Recommended dosing is a baseline injection followed by another injection at week four, followed by subsequent injections every 12 weeks.7 Serious infections have been reported in clinical trials. Therefore, the company has developed a Risk Evaluation and Mitigation Strategy (REMS), as well as targeted healthcare provider education and a patient guide. The product label also contains cautions related to potential immunosuppression, as well as information on avoiding live vaccines while being treated with the agent.
- Cladribine, originally approved by the FDA in an intravenous formulation in the 1990s to treat hairy cell leukemia, has been reformulated as an oral product to manage patients with multiple sclerosis.8 Merck has submitted oral cladribine as a disease-modifying therapy for multiple sclerosis. If approved, it will be the first oral disease modifying agent for treating multiple sclerosis patients.9
- Dapagliflozin, a new mechanism renal sodium-glucose co-transporter 2 (SGLT2) inhibitor, has been shown to reduce fasting plasma glucose and significantly reduce HbA1c levels in patients with Type 2 diabetes mellitus, compared with patients treated with a metformin and placebo combination.10,11 Additionally, about 25% of patients treated with dapagliflozin (vs. 6% of the placebo-metformin-treated patients) had at least a 5% decrease in body weight. Diastolic blood pressure and uric acid level also decreased but not significantly. Serious adverse events were similar between the two treated groups.
- Fingolimod, an oral, disease-modifying agent to treat multiple sclerosis, is the first in a new class of agents known as sphingosine 1-phosphate receptor modulators (S1P-R). A recent two-year study showed it significantly reduced both relapses and disability progression (compared with placebo) in patients with relapsing remitting multiple sclerosis.12,13 More information will be available on this agent.
- Naproxcinod is a cyclo-oxygenase-inhibiting nitric oxide donator (CINOD) anti-inflammatory agent.14 The proposed indication is for the relief of the signs and symptoms of osteoarthritis, predominantly for pain management.
- Promethazine injection has undergone a label change to include a boxed warning. The warning is to emphasize the risk of serious tissue injury when promethazine is incorrectly administered.15 The preferred route is deep intramuscular injection; if administered in or near a vein, severe tissue injury might occur. The FDA previously informed healthcare professionals about the risks of incorrectly administered promethazine in December 2006 and again in February 2008. Post-marketing adverse events reported from 1969 to 2009 have identified cases of gangrene requiring amputation associated with administration of injectable promethazine.
- Since its original FDA approval in October 2006, sitagliptin, the first oral dipeptidyl peptidase-4 (DPP-4) inhibitor, is undergoing a safety label change.16 There have been 88 post-marketing cases reported of acute pancreatitis, including two cases of necrotizing or hemorrhagic pancreatitis reported between Oct. 16, 2006, and Feb. 9, 2009.17 The updated labeling discusses more information on the pancreatitis cases reported, and recommends that healthcare professionals carefully monitor patients for the development of pancreatitis, either upon beginning therapy or around dose increases. TH
Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.
- Japan’s Astellas settles with Impax on prostate drug. Reuters Web site. Available at: http://www.reuters.com/article/rbssPharmaceuticals%20-%20Generic%20&%20Specialty/idUST28251320091007. Accessed Oct. 13, 2009.
- FDA approves Berinert. Drugs.com Web site. Available at: http://www.drugs.com/newdrugs/csl-behring-announces-fda-approval-berinert-first-only-therapy-approved-acute-abdominal-facial-1681.html. Accessed Oct. 13, 2009.
- Welchol package label. FDA Web site. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022362lbl.pdf. Accessed Oct. 13, 2009.
- Walker E. FDA Panel recommends approval of new oxycodone formulation. Medpage Today Web site. Available at: http://www.medpagetoday.com/Neurology/PainManagement/16132?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news. Accessed Oct. 13, 2009.
- Todoruk M. FDA panel supports approval of Schering-Plough’s PegIntron for patients with melanoma. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=8E68078692384C8A8249EA4A4C036635&logRowId=330581. Accessed Oct. 13, 2009.
- Gever J, Agus ZS. FDA approves biologic drug for psoriasis. Medpage Today Web site. Available at: http://www.medpagetoday.com/InfectiousDisease/PublicHealth/16147?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news. Accessed Oct. 13, 2009.
- Stelara package label. FDA Web site. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261lbl.pdf. Accessed Oct. 13, 2009.
- Leustatin package label. FDA Web site. Available at: http://www.cancerconsultants.com/druginserts/Cladribine.pdf. Accessed Oct. 13, 2009.
- Todoruk M. Merck KGaA files cladribine for FDA approval. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=08CF20114B2A4F1DA8FD33AAC7240AB8&logRowId=329839. Accessed Oct. 2, 2009.
- Dennis M. AstraZeneca, Bristol-Myers Squibb’s dapagliflozin meets endpoints in Phase III study. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=3B158484CA7A47B99CEA373CB2ABFFA2&logRowId=330336. Accessed Oct. 13, 2009.
- Gever J, Zaleznik DF, Caputo D. EASD: Phase III data look good for novel diabetes drug. Medpage Today Web site. Available at: http://www.medpagetoday.com/MeetingCoverage/EASD/16270. Accessed Oct. 11, 2009.
- Dennis M. Novartis: Phase III study shows oral MS drug fingolimod reduces relapses, disability progression. FirstWord Web site. Available at: http://www.firstwordplus.com/Fws.do?articleid=EDBA0E3366E2477DB714674E9C19821D&logRowId=329838. Accessed Oct. 13, 2009.
- Multiple sclerosis therapy FTY720 reduces relapses and disability progression. The Multiple Sclerosis Resource Centre Web site. Available at: http://www.msrc.co.uk/printable.cfm?pageid=1309. Accessed Oct. 13, 2009.
- NicOx submits New Drug Application (NDA) for naproxcinod to the US FDA. NicOx Web site. Available at: http://www.nicox.com/upload/PR_NDA_submission-250909__EN.pdf. Accessed Oct. 13, 2009.
- Riley K. FDA requires boxed warning for promethazine hydrochloride injection. FDA Web site. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182498.htm. Accessed Oct. 13, 2009.
- Januvia package label. FDA Web site. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021995lbl.pdf. Accessed Oct. 13, 2009.
- Information for healthcare professionals—acute pancreatitis and sitagliptin (marketed as Januvia and Janumet). FDA Web site. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm183764.htm. Accessed Sept. 26, 2009.