Abstract
This monthly feature will help readers keep current on new drugs, indications, dosage forms, and safety-related changes in labeling or use.
New Drugs Approved By The FDA: September 1 to December 18, 2005
| Generic Name | Brand Name (Company) | Indication | Dosage Form and Strength (Date of Approval) | Product Information Web Site |
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iPlex (Insmed) | Treatment of growth failure in children with severe primary IGF-1 deficiency (primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH | Injection 36 mg/0.6 mL (12/05) | http://www.insmed.com/PDF/iPLEX_package_insert.pdf |
| Deferasirox | Exjade (Novartis) | Treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) | Tablet 125, 250, 500 mg (11/05) | http://www.fda.gov/cder/foi/label/2005/021882lbl.pdf |
| Estradiol/drospirenone | Angeliq (Berlex) | Indicated in women who have a uterus for the:
Treatment of moderate-to-severe vasomotor symptoms associated with the menopause. Treatment of moderate-to-severe symptoms of vulvar and vaginal atrophy associated with menopause When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered |
Tablet 1 mg/0.5 mg (10/05) |
http://www.fda.gov/cder/foi/label/2005/021355lbl.pdf |
| Measles, mumps, rubella, and varicella virus vaccine live | ProQuad (Merck) | Prevention of measles, mumps, rubella, and chickenpox in children 12 months to 12 years of age | Injection (9/05) | http://www.fda.gov/cber/label/mmrvmer090605LB.pdf |
| Nelarabine | Arranon (Glaxo-Smith-Kline) | Treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens | Injection 250 mg vial 5 mg/mL (10/05) | http://www.fda.gov/cder/foi/label/2005/021877lbl.pdf |
New Dosage Forms and Indications Approved By the FDA: October 1 to December 18, 2005
| Generic Name | Brand Name (Company) | Indication | Dosage Form (Date) |
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Xopenex HFA (Sepracor) | Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease | Inhaler (12/05) |
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(Teva) | Approval of lower-dosage strengths: 10, 20, and 40 mg | Tablet (12/05) |
| Clobetasol propionate | Clobex (Galderma) | Spray for the treatment of moderate-to-severe plaque psoriasis | Spray (10/05) |
| Fenofibrate | Antara (Reliant Pharmaceuticals) | New dosing information allows for ingestion with or without food | Capsule (11/05) |
| Glipizide/metformin | Metaglip (Bristol Myers Squibb) | Treatment of diabetes | Tablet (10/05) |
| Lopinavir/ritonavir | Kaletra (Abbott) | New tablet formulation that decreases the pill burden that can be taken with or without food and requires no refrigeration | Tablet (10/05) |
| Pegaspargase | Oncaspar (Enzon Pharmaceuticals) | Intravenous administration is now approved, but the preferred method of administration is still intramuscular injection when possible | Injection (11/05) |
| Tamoxifen | Soltamox (Savient Pharmaceuticals) | Oral liquid for the treatment of breast cancer | Liquid (10/05) |
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Depakote ER (Abbott) | Treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features | Tablets (12/05) |
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Avelox (Schering-Plough) | Treatment of complicated intra-abdominal infections in adults | Tablets/injection (11/05) |
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Xyrem (Jazz Pharmaceuticals) | Treatment of patients with narcolepsy who experience episodes of cateplexy | Solution (11/05) |
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Effexor XR (Wyeth) | Treatment of adults with panic disorders | Tablet (11/05) |
| Adalimumab | Humira (Abbott) | Reduction of signs and symptoms of active arthritis in patients with psoriatic arthritis; first-line treatment of recent onset moderate-to-severe rheumatoid arthritis | Injection (10/05) |
| Erlotinib | Tarceva (OSI Pharmaceuticals) | Treatment of advanced pancreatic cancer in combination with gemcitabine in patients who have not received previous chemotherapy | Tablet (11/05) |
| Ertapenem | Invanz (Merck) | Treatment of moderate-to-severe complicated foot infection due to indicated pathogens in diabetic patients without osteomyelitis | Injection (11/05) |
| Exemestane | Aromasin (Pfizer) | Adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer, who have received 2 to 3 years of tamoxifen and are switched to exemestane for completion of a total of 5 consecutive years of adjuvant hormonal therapy | Tablet (10/05) |
| Insulin detemir (rDNA origin) | Levemir (Novo Nordisk) | Treatment of diabetes in children | Injection (10/05) |
| Ritonavir | Norvir (Abbott) | Approved dosing recommendations added for pediatric patients 1 month to 2 years of age | Solution/capsule (10/05) |
Agents Pending Fda Approval
| Generic Name | Brand Name (Company) | Indication/Comment | Date |
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Fuzeon (Roche/Trimeris) | Needle-free injection device using Biojector 2000 | 11/05 |
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Daytrana (Shire) | Treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years | 12/05 |
| Abetimus | Riquent (La Jolla Pharmaceutical) | Treatment of lupus | 10/04 |
| Alvimopan | Entereg (Adolor Corp/GlaxoSmithKline) | Treatment of postoperative ileus in patients recovering from bowel surgery | 7/05 |
| Anecortave acetate | Retaane (Alcon) | Treatment of wet age-related macular degeneration | 5/05 |
| Anidulafungin | (Vicuron Pharmaceuticals) | Treatment of esophageal candidiasis | 5/04 |
| Ciclesonide | Alvesco (Sanofi-Aventis) | Treatment of asthma | 10/04 |
| Cilomilast | Ariflo (GlaxoSmithKline) | Treatment of patients with COPD who are poorly responsive to albuterol | 10/03 |
| Clodronate | Bonefos (Berlex Laboratories) | Adjuvant oral treatment for reducing the occurrence of bone metastases in stage II/III breast cancer patients | 1/05 |
| Conivaptan | Vaprisol (Yamanouchi Pharma) | Treatment of hyponatremia | 12/04 |
| Cromolyn sodium | Intal HFA (King Pharmaceuticals) | HPA propellant formulation for the treatment of asthma | 10/03 |
| Cyclosporine | Pulminiq (Chiron) | Aerosolized formulation for use in lung transplantation | 6/05 |
| Dextroamphetamine/amphetamine | Adderall XR (Shire) | Treatment for adults with ADHD | 10/03 |
| Etonogestrel | Implanon (Organon) | Contraceptive | 6/05 |
| Everolimus | Certican (Novartis) | Prevention of rejection after heart and kidney transplantation | 10/03 |
| Fentanyl | Ionsys (ALZA Corporation) | Iontophoretic fentanyl-containing transdermal analgesic | 7/04 |
| Ferumoxtran-10 | Combidex (Advanced Magnetics/Cytogen Corporation) | Used in conjunction with magnetic resonance imaging (MRI) to aid in the differentiation of cancerous from noncancerous lymph nodes | 9/04 |
| Formoterol | Foradil Certihaler (SkyePharma) | Dry powder inhaler for treatment of asthma and COPD | 10/03 |
| Hyaluronic acid | Orthovisc (Anika Therapeutics) | Treatment of osteoarthritis of the knee | 12/03 |
| Levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg | Seasonique (Barr Pharmaceutical) | Extended-cycle oral contraceptive | 8/05 |
| Lucinactant | Surfaxin (Discovery Laboratories) | Treatment of respiratory distress syndrome in premature infants | 2/05 |
| Metformin | Fortamet (Andrx Corporation) | Extended-release tablet for once-daily treatment of diabetes | 10/03 |
| Metformin hydrochloride | Glumetza (Biovail Corporation) | Extended-release formulation for the treatment of type 2 diabetes; the 500 mg strength uses Depomed's Gastric Retention drug-delivery technology, and the 1,000 mg strength uses Biovail's Smartcoat delivery technology | 3/05 |
| Modafinil | Sparlon (Cephalon) | Treatment of attention-deficit/hyperactivity disorder in children and adolescents ages 6 to 17 years | 10/05 |
| Muraglitazar | Pargluva (Bristol-Myers Squibb) | Treatment of type 2 diabetes, as monotherapy or in combination with metformin | 10/05 |
| Nebivolol | (Mylan) | Treatment of hypertension | 6/05 |
| Oxypurinol | Oxyprim (Cardiome) | Treatment of allopurinol-intolerant hyperuricemia | 6/04 |
| Ranolazine | Ranexa (CV Therapeutics) | Treatment of chronic stable angina | 10/03 |
| Selegiline | Emsam Patch (Mylan Laboratories/Waston Pharmaceuticals) | Treatment of depression | 2/04 |
| SnET2 | (Miravant Medical Technologies) | Slow the progression of wet age-related macular degeneration | 10/04 |
| Thalidomide | Thalomid (Celgene) | Treatment of multiple myeloma | 11/05 |
| Tramadol ODT | (Biovail) | Orally disintegrating tablet for the treatment of moderate-to-severe pain | 1/05 |
| Travoprost/timolol | Extravan (Alcon) | Treatment of glaucoma | 9/04 |
| Vapreotide | Sanvar IR (H3 Pharma) | Treatment of acute esophageal variceal bleeding secondary to portal hypertension | 1/05 |
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Zostavax (Merck) | Prevention of herpes zoster (shingles), prevention of postherpetic neuralgia, and reduction of shingles-associated pain | 12/05 |
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RotaTeq (Merck) | Prevention of rotavirus gastroenteritis | 12/05 |
| Abatacept | Orencia (Bristol-Myers Squibb) | Treatment of moderately-to-severely active rheumatoid arthritis | 9/05 |
| Erlotinib | Tarceva (OSI Pharmaceuticals) | Erlotinib plus gemcitabine as a first-line treatment for advanced pancreatic cancer in chemotherapy-naïve patients | 9/05 |
| Insulin, inhaled | Exubera (Pfizer) | Treatment of adults with type 1 or 2 DM | 9/05 |
| Lenalidomide | Revlimid (Celgene) | Treatment of myelodysplastic syndromes | 9/05 |
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(Inspire Pharmaceuticals) | Treatment of dry eye disease | 12/05 |
| Dapoxetine | (Johnson & Johnson) | Treatment of premature ejaculation | 10/05 |
| Everolimus | Certican (Novartis Pharmaceuticals) | Prophylaxis of rejection in heart transplantation | 11/05 |
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Xenical (Roche) | Switch to OTC status for the treatment of obesity | 1/06 |
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Factive (Oscient) | 5-day treatment for acute bacterial sinusitis and mild-to-moderate community-acquired pneumonia | 11/05 |
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Elaprase (Shire) | Treatment of Hunter syndrome | 11/05 |
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(Johnson & Johnson) | Treatment of schizophrenia | 11/05 |
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Gardasil (Merck) | Prevention of cervical cancer | 12/05 |
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(Spectrum Pharmaceuticals/GPC Biotech AG) | Rolling NDA for second-line chemotherapy for patients with hormone-refractory prostate cancer | 12/05 |
Significant Labeling Changes or “Dear Health Professional Letters” Related to Safety
| Generic Name Brand Name (Company) | Warning | Web Site |
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| The CLARICOR Study reported an increased mortality in patients treated with clarithromycin (14 days) compared with patients who received a placebo. The difference in mortality became apparent after patients were followed for 1 year or longer after the study drug was given. The FDA is not recommending any specific changes to the use of clarithromycin at this time. | http://www.fda.gov/cder/drug/infopage/clarithromycin/default.htm | |
| The warning sections and Medication Guide for patients need to alert health care professionals and patients that these medicines may increase the chance of severe asthma episodes and death when those episodes occur. The Medication Guide with information about these risks will be required to accompany all filled or refilled prescriptions for these products. | http://www.fda.gov/cder/drug/advisory/LABA.htm | |
| WARNING: minimum observation period after administration should be 1 hour and increased if the patient has had a previous infusion reaction. | http://www.fda.gov/medwatch/SAFETY/2005/Sep_PI/Zevalin_PI.pdf | |
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CONTRAINDICATIONS: avoid when one or more of the following conditions exist: acute pelvic inflammatory disease (PID), or current behavior suggesting a high risk for PID; postpartum endometritis or postabortal endometritis in the past 3 months; mucopurulent cervicitis; allergy to any component of ParaGard; and a previously placed intrauterine device (IUD) that has not been removed. WARNINGS: updated sections include intrauterine pregnancy; ectopic pregnancy; pelvic infection; immunocompromise; embedment; perforation; expulsion; and Wilson Disease. |
http://www.fda.gov/medwatch/SAFETY/2005/Sep_PI/ParaGard_PI.pdf | |
| Increased risk of ergotism when used with ergot alkaloids or their derivatives. | http://www.fda.gov/medwatch/SAFETY/2005/Sep_PI/Minocin_Injection_PI.pdf | |
| Change in pregnancy category from C to D. Increased risk of heart defects in infants born to mothers that used paroxetine during the first trimester. | http://www.fda.gov/bbs/topics/NEWS/2005/NEW01270.html | |
| CONTRAINDICATIONS AND WARNINGS: concurrent use with ritonavir and rifampin should be avoided due to increase risk of severe hepatocellular toxicity. | http://www.fda.gov/medwatch/SAFETY/2005/Sep_PI/Invirase_PI.pdf | |
| NEW WARNING: male patients requiring phacoemulsification cataract surgery may develop a surgical condition termed Intraoperative Floppy Iris Syndrome (IFIS) following the procedure. Stopping the alpha-1 blocker, prior to surgery, may not prevent its development, so all patients should be warned of this risk—prior to the procedure and monitored for the development of IFIS after the procedure has been completed. | http://www.fda.gov/medwatch/SAFETY/2005/Flomax_dearhcp_nov22_PI.pdf |