New FDA Approvals
December 1, 2003 3 minutes read
These drugs recently received final approval from the U.S. Food and Drug Administration (FDA):
• New delivery system of peginterferon alfa-2b (PegIntron Redipen) by Schering-Plough Corp. The FDA has approved peginterferon alfa-2b (PegIntron Redipen), a pre-filled pen for administering peginterferon alfa-2b powder for injection, the most-prescribed interferon treatment for patients with chronic hepatitis C.
The pen is a disposable, single-dose delivery system that allows patients to administer the drug in three steps: mix, dial, and deliver. Mixing occurs by pushing down on the pen to combine the peginterferon alfa-2b powder with sterile water, both of which are stored in the pen. Dialing allows patients to select their predetermined individualized dose, and delivery allows patients to inject their individualized dose of the medication. The pen will be available in four different strengths: 50, 80, 120, and 150 mcg, each indicated by a color-coded label and dosing button. An instructional videotape and brochure for use by patients and health care professionals will also be available. The pen is expected to be available in the United States in early 2004.
• Fosamprenavir calcium (Lexiva) by GlaxoSmithKline. The FDA has approved fosamprenavir calcium (Lexiva), a protease inhibitor (PI), for the treatment of HIV infection in adults in combination with other antiretroviral medications. Fosamprenavir calcium, which can be taken once or twice daily without food or water restrictions, has been evaluated in clinical trials with both PI-experienced and antiretroviral therapy (ART)-naive HIV patients.
GlaxoSmithKline says the following points should be considered when initiating therapy with fosamprenavir calcium/ritonavir in PI-experienced patients: The PI-experienced patient study was not large enough to reach a definitive conclusion that fosamprenavir calcium/ritonavir and lopinavir/ritonavir are clinically equivalent. Once-daily administration of fosamprenavir calcium plus ritonavir is not recommended for PI-experienced patients.
Fosamprenavir calcium may be dosed three different ways: 1) two 700 mg tablets twice daily (bid); 2) two 700 mg tablets once daily (QD) in combination with two 100 mg capsules of ritonavir QD; or 3) one 700 mg tablet bid in combination with one 100 mg capsule of ritonavir bid. For PI-experienced patients, the recommended dose is one 700 mg tablet bid in combination with one 100 mg capsule of ritonavir bid.
Fosamprenavir calcium was well-tolerated in clinical trials. The most common adverse events were diarrhea, nausea, vomiting, headache, and rash. Fosamprenavir calcium is contraindicated in patients with previously demonstrated clinically significant hypersensitivity to any of the components of this product or to amprenavir. The drug is also contraindicated with ergot derivatives, cisapride, pimozide, midazolam, and triazolam. If fosamprenavir calcium is coadministered with ritonavir, flecainide and propafenone also are contraindicated.
• New indication for nateglinide (Starlix) by Novartis Pharmaceuticals Corp. The FDA has approved nateglinide (Starlix) for use in combination with a thiazolidinedione (TZD) in patients with Type 2 diabetes who are not adequately controlled after a therapeutic response to a TZD. Nateglinide was approved in the United States in 2001 as monotherapy for drug-naive patients with Type 2 diabetes and in combination with metformin.
The most common adverse events associated with nateglinide vs. placebo in clinical trials were upper respiratory infection, back pain, flu symptoms, dizziness, arthropathy, and hypoglycemia. Based on the safety and tolerability in clinical trials, no liver function testing or special monitoring is required when nateglinide is used in monotherapy. In patients whose hyperglycemia is inadequately controlled with metformin or after a therapeutic response to a TZD, nateglinide may be added to, but not substituted for, those drugs.
• New dosing for levofloxacin (Levaquin) by Ortho-McNeil Pharmaceutical. The FDA has approved levofloxacin (Levaquin) tablets/injection and levofloxacin in 5% dextrose injection 750 mg once-daily regimen to treat mild-to-severe community acquired pneumonia (CAP). With this approval, the drug becomes the only short-course fluoroquinolone indicated to treat CAP in a five-day regimen.
Levofloxacin is dosed once daily and indicated for a wide variety of infections including CAP, nosocomial pneumonia, mild-to-moderate cases of complicated urinary tract infections, acute pyelonephritis, uncomplicated urinary tract infections, acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, and chronic bacterial prostatitis. Levofloxacin is contraindicated in persons with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product.
These drugs recently received final approval from the U.S. Food and Drug Administration (FDA):You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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