FDA Approves Apidra, Nasacort HFA, Ziagen, New Zantac Dose, New Proscar Regimen

April 22, 2004

Yael Waknine

April 22, 2004 The U.S. Food and Drug Administration (FDA) has approved insulin glulisine injection for diabetes, triamcinolone acetonide nasal aerosol for allergic rhinitis, abacavir sulfate for HIV infection, a pediatric dose for ranitidine hydrochloride, and a new indication for finasteride.

Insulin Glulisine of rDNA Origin (Apidra) for Diabetes

Insulin glulisine (Apidra, made by Aventis) was approved by the FDA this week for the treatment of adult patients with diabetes mellitus and for the control of hyperglycemia.

Insulin glulisine is a novel recombinant DNA human insulin analogue that has a more rapid onset and shorter duration of action than regular human insulin after subcutaneous administration.

According to an Aventis news release, Apidra is designed to cover mealtime blood sugar spikes. When used in combination with insulin glargine (Lantus), a 24-hour basal insulin, it offers a synergistic approach to total glucose control.

Triamcinolone Acetonide Nasal Aerosol (Nasacort HFA) for Allergic Rhinitis

Triamcinolone acetonide nasal aerosol (Nasacort HFA, made by Aventis) was approved by the FDA on April 15 for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in adults and children aged six years and older.

According to a news release from Aventis, this is the first intranasal corticosteroid dry-aerosol formulation approved in the U.S. that contains hydrofluoroalkane (HFA) rather than chlorofluorocarbons (CFCs).

Nasacort HFA replaces the Nasacort Nasal Inhaler, removed from the U.S. market in July 2003 in compliance with FDA and Environmental Protection Agency requirement banning the use of CFC products, which are intended to protect the ozone layer.

Abacavir Sulfate (Ziagen) for the Treatment of HIV Infection

Abacavir sulfate (Ziagen, made by GlaxoSmithKline) received traditional FDA approval on April 16 for the treatment of HIV infection in combination with other antiretroviral medications.

Abacavir sulfate, a nucleoside reverse transcriptase inhibitor, received fast-track approval in December 1998. This new traditional approval is based on the results of clinical trials confirming the benefits of the drug in combination with lamivudine and efavirenz.

Ranitidine Hydrochloride Effervescent (Zantac Efferdose) for Pediatric Treatment of GERD

A new dose of ranitidine hydrochloride effervescent tablets (Zantac Efferdose, made by GlaxoSmithKline) was approved by the FDA on April 12 for the treatment of gastroesophageal reflux disease (GERD) in children aged one month and older.

The 25-mg tablet is intended to be dissolved in at least 5 mL of water and then administered to the infant or child. According to a company news release, the taste of the tablet formulation is preferred by children over Zantac syrup and accommodates convenient dosing regimens for patients weighing 11 to 22 lb with GERD.

Finasteride (Proscar) Combined with Doxazosin to Reduce Risk of BPH Symptom Progression

This week, the FDA approved changes to the prescribing information for finasteride (Proscar, made by Merck & Co.) that include administration with the alpha-blocker doxazosin to reduce the risk of progression of symptoms associated with benign prostatic hyperplasia (BPH) over time.

The new indication is based on the results of a multicenter, double-blind, placebo-controlled study involving 3,047 patients and published in the Dec. 18, 2003, issue of the New England Journal of Medicine. Finasteride combined with doxazosin was found to reduce the risk of symptom score progression by 64%.

Reviewed by Gary D. Vogin, MD

Yael Waknine is a freelancewriter for Medscape.

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