Drug Criteria & Outcomes: New FDA Approvals
Drug Criteria & Outcomes: New FDA Approvals
These drugs recently received final approval from the U.S. Food and Drug Administration (FDA):
• A combination vaccine by SmithKline Beecham Pharmaceuticals that protects against diphtheria, tetanus, pertussis, polio, and disease due to the hepatitis B virus (Pediarix). The FDA has approved this combination vaccine for children. The vaccine (Pediarix) is the only vaccine marketed in the United States that contains DTaP (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed), hepatitis B vaccine (recombinant), and inactivated poliovirus vaccine (IPV) for administration as one intramuscular injection.
The vaccine is recommended for administration as a three-dose primary series to infants at approximately 2, 4, and 6 months of age. Infants receive nine injections when DTaP, hepatitis B, and IPV vaccines are administered separately in the same time frame. The combination vaccine should not be administered to infants before the age of 6 weeks, and therefore is not indicated for infants born to mothers who are infected with hepatitis B or whose hepatitis B status is unknown. Such infants should receive hepatitis B vaccine shortly after birth and complete their immunization according to a particular schedule.
In clinical trials, the most frequently reported adverse reactions to the vaccine were local injection site reactions (pain, redness, swelling), fever, and fussiness. Fever occurred more frequently after administration of the vaccine than separately administered licensed vaccines.
• New indication for docetaxel (Taxotere) by Aventis. The FDA has approved docetaxel (Taxotere) for Injection Concentrate as first-line therapy in combination with cisplatin in patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. With this approval, docetaxel is the first new treatment option for the first-line treatment of NSCLC patients in more than four years.
Taxotere previously had been approved in the United States to treat patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy, and patients with locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy.
• New formulation for ciprofloxacin (Cipro) by Bayer Corp. The FDA has approved ciprofloxacin extended-release tablets (Cipro XR), a new formulation of ciprofloxacin, given once a day over three days, for the treatment of uncomplicated urinary tract infections (UTIs) due to susceptible strains of indicated organisms. The new formulation will be marketed at a dosage strength of 500 mg.
Ciprofloxacin extended-release tablets were developed using a bilayer matrix of the active ingredient ciprofloxacin, and enables two different release mechanisms. The first is a rapid release of ciprofloxacin, which distributes to the serum and tissues within hours. This is followed by a second extended release of the active ingredient to allow sustained levels over 24 hours.
• New indication for clozapine (Clozaril) by Novartis Pharmaceuticals Corp. The FDA has approved clozapine (Clozaril) for the treatment of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are at chronic risk. This action by the FDA marks the first time that any medication has been approved for use in treatment of suicidal behavior. Although generic versions of Clozaril are available, FDA regulations provide Novartis with exclusive rights to market the new indication for a period of 36 months.
• New indication for linezolid injection, tablets, and oral suspension (Zyvox) by Pharmacia Corp. The FDA has approved the supplemental new drug application of linezolid injection, tablets, and oral suspension (Zyvox) for the treatment of gram-positive infections in infants and children, which include complicated skin and skin structure infections and nosocomial (hospital-acquired) pneumonia. The FDA approval also included the treatment of community-acquired pneumonia, uncomplicated skin and skin structure infections, and vancomycin-resistant Enterococci faecium in infants and children.
Zyvox was approved for use in adults in the United States in April 2000.
• New indication for imatinib mesylate (Gleevec) by Novartis. The FDA has approved imatinib mesylate (Gleevec) for first-line treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML). Gleevec also is indicated for the treatment of patients with Ph+ CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. In addition, Gleevec received FDA approval in February 2002 for the treatment of patients with Kit (CD 117) positive unresectable (inoperable) and/or metastatic malignant gastrointestinal stromal tumors.
• New indication for clobetasol propionate (Olux) by Connetics. The FDA has approved clobetasol propionate (Olux) Foam, 0.05%, to include the short-term topical treatment of mild-to-moderate plaque-type psoriasis of non-scalp regions excluding the face and intertriginous areas. Clobetasol propionate previously was approved for the short-term topical treatment of the inflammatory and pruritic manifestations of moderate-to-severe corticosteroid-responsive dermatoses of the scalp including psoriasis.
• Approval for fluoxetine (Prozac) by Eli Lilly for children and adolescents. The FDA has approved the antidepressant fluoxetine (Prozac) to treat children and adolescents 7-17 years of age for depression (major depressive disorder) and obsessive-compulsive disorder. This is the first approval of one of the newer types of antidepressants (selective serotonin reuptake inhibitors, or SSRIs) for treating depression in this population. (Fluoxetine also is approved for major depressive disorder in adults, bulimia, and panic disorder.)
Common side effects associated with use of fluoxetine in children and adolescents were similar to those experienced by adults and include nausea, tiredness, nervousness, dizziness, and difficulty concentrating. One clinical trial in children and adolescents 8-17 years of age showed a slight growth inhibition after 19 weeks of treatment with fluoxetine; Lilly has agreed to conduct a Phase IV postmarketing study to further evaluate any potential impact of fluoxetine on long-term growth in children.
• Eletriptan hydrobromide (Relpax) by Pfizer. The FDA has approved eletriptan hydrobromide (Relpax) for the acute treatment of migraine.
In clinical trials involving more than 9,000 patients and more than 70,000 migraine attacks, eletriptan hydrobromide was shown to relieve migraine pain and associated symptoms such as nausea and sensitivity to light and sound. Eletriptan hydrobromide was shown to be effective at doses of 20 mg, 40 mg, and 80 mg. The maximum recommended single dose of eletriptan hydrobromide is 40 mg.
The most common side effects reported in clinical trials included fatigue, somnolence, nausea, and dizziness. Eletriptan hydrobromide should not be used by patients with severe hepatic impairment, or those older than 65 years or younger than 18 years. Eletriptan hydrobromide tablets also should not be used within at least 72 hours of potent CYP3A4 inhibitors.
• New indication for latanoprost ophthalmic solution (Xalatan) by Pharmacia Corp. The FDA has approved the once-daily prescription eye drop latanoprost ophthalmic solution (Xalatan) as an initial treatment for elevated eye pressure associated with open-angle glaucoma or ocular hypertension. Latanoprost ophthalmic solution was introduced in the United States in 1996 as the first prostaglandin-based intraocular pressure-lowering medication. The FDA initially approved the medication for second-line use.
These drugs recently received final approval from the U.S. Food and Drug Administration (FDA).
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