- Resource Centers
Diovan HCT (valsartan/hydrochlorothiazide)
Marketed by: Novartis Pharmaceuticals Corp (East Hanover, NJ)
Indication: May 1, 2006?The FDA approved 2 new higher-dose formulations of Novartis'high blood pressure medication, Diovan HCT. The approval of the higher strengths (320/12.5 mg and 320/25 mg) provides more options for the effective management of patients'high blood pressure. Diovan HCT is a combination of the efficacious blood pressure medicine Diovan (valsartan), an angiotensin receptor blocker, and the diuretic hydrochlorothiazide.
Dosage Form: Tablets: 80/12.5, 160/12.5, 160/25, 320/12.5, and 320/25 mg
For More Information: www.novartis.com
Focalin XR (dexmethylphenidate HCl)
Marketed by: Novartis Pharmaceuticals Corp (East Hanover, NJ)
Indication: May 23, 2006?The FDA approved updated labeling for the attention-deficit/hyperactivity disorder (ADHD) medication Focalin XR extended-release capsules. This change in labeling describes studies showing that Focalin XR works fast and is effective for up to 12 hours. These 2 additional studies in pediatric patients aged 6 to 12 showed statistically significant improvements in ADHD symptoms of attention and behavior versus placebo at every hour up to and including 12 hours after administration. Focalin XR is indicated for the treatment of ADHD in adults, adolescents, and children.
Dosage Form: Capsules: 5, 10, and 20 mg
For More Information: www.FocalinXR.com
Genotropin (somatropin [rDNA origin] for injection)
Marketed by: Pfizer Inc (New York, NY)
Indication: May 4, 2006?Pfizer's Genotropin, a sterile white lyophilized powder intended for subcutaneous injection, was approved by the FDA for the long-term treatment of growth failure associated with Turner's syndrome in patients whose bones are still capable of growing. Turner's syndrome is a growth-related disorder affecting nearly 60,000 girls and women in the United States, with roughly 800 new cases diagnosed each year. Genotropin also is approved for the longterm treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone and due to Prader-Willi syndrome, and also for the long-term treatment of growth failure in children born small for gestational age who fail to manifest catch-up growth by age 2.
Dosage Form: 1.5-mg 2-chamber cartridge (without preservative)?concentration of 1.3 mg/mL; 5.8-mg 2-chamber cartridge (with preservative)?concentration of 5 mg/mL; 13.8-mg 2-chamber cartridge (with preservative)?concentration of 12 mg/mL
For More Information: www.pfizer.com
Keflex (cephalexin capsules, USP)
Marketed by: Advancis Pharmaceutical Corp (Germantown, Md)
Indication: May 15, 2006?Advancis Pharmaceutical Corp received FDA approval to market 2 new strengths, 333 mg and 750 mg, of the company's antibiotic Keflex. The new Keflex 750-mg strength provides a more convenient way to deliver a total daily dose of 1500 mg through the ability to use just 2 daily doses of the 750-mg capsules. It is indicated for the treatment of respiratory tract infections, otitis media, skin and skin structure infections, bone infections, and genitourinary tract infections.
Dosage Form: Capsules: 250, 333, 500, and 750 mg
For More Information: www.advancispharm.com/products/keflex 877-363-8080
Mirapex (pramipexole dihydrochloride)
Marketed by: Boehringer Ingelheim Pharmaceuticals Inc (Ridgefield, Conn)
Indication: April 3, 2006?Mirapex has new National Drug Code numbers, bottles, and tablet imprints. Boehringer Ingelheim Pharmaceuticals Inc increased the number of tablets in the 0.125-mg dose bottle from 63 to 90. Now, all doses will be available with 90 tablets per bottle. The front of each tablet will contain the initials "BI," and the reverse side will have a 2-digit code. Mirapex is indicated for the treatment of signs and symptoms of idiopathic Parkinson's disease.
Dosage Form: Tablets: 0.125, 0.25, 0.5, 1, and 1.5 mg
For More Information: www.mirapex.com 800-243-0127
Nexium (esomeprazole magnesium)
Marketed by: AstraZeneca (Wilmington, Del)
Indication: May 1, 2006?The FDA approved the use of Nexium delayedrelease capsules in adolescents aged 12 to 17 for the short-term treatment of gastroesophageal reflux disease (GERD). GERD affects nearly 3 million adolescents every year. Nexium is indicated for the treatment of GERD?including healing of erosive esophagitis, maintenance of healing of erosive esophagitis, and symptomatic GERD.
Dosage Form: Capsules: 20 and 40 mg
For More Information: www.nexium-us.com
Marketed by: Centocor Inc (Horsham, Pa)
Indication: May 22, 2006?Remicade was approved by the FDA for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderate-to-severe active Crohn's disease who have had an inadequate response to conventional therapy. With this approval, Remicade is the only biologics therapy approved for the treatment of pediatric Crohn's disease.
Dosage Form: Intravenous: 5 mg/kg
For More Information: www.remicade.com 888-779-9769
Seasonique (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg)
Marketed by: Duramed Pharmaceuticals Inc (Woodcliff Lake, NJ)?a subsidiary of Barr Pharmaceuticals
Indication: May 25, 2006?The FDA approved Duramed Pharmaceuticals Inc's Seasonique extended-cycle oral contraceptive for the prevention of pregnancy. Seasonique represents the next generation of extended- cycle oral contraceptives.
Dosage Form: Extended-cycle tablet dispensers: 84 light blue-green tablets containing 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol; and 7 yellow tablets containing 0.01 mg ethinyl estradiol
For More Information: www.seasonique.com
Zostavax (zoster vaccine live [Oka/Merck])
Marketed by: Merck & Co Inc (Whitehouse Station, NJ)
Indication: May 26, 2006?The FDA licensed Zostavax, a new vaccine to reduce the risk of shingles (herpes zoster) for use in people 60 years of age and older. Zostavax is a live virus vaccine shown to boost immunity against varicella-zoster virus, the virus that causes shingles as well as chickenpox. Shingles is estimated to affect 2 in every 10 people in their lifetime. Zostavax is given as a single injection under the skin, preferably in the upper arm.
Dosage Form: Package of 1 single-dose vial of lyophilized vaccine, and a separate package of 10 vials of diluent; or a package of 10 single-dose vials of lyophilized vaccine and a separate package of 10 vials of diluent
For More Information: www.merck.com