New dosing option approved for Viracept
The FDA has approved a new alternate dosing formulation of Viracept (nelfinavir mesylate). Viracept has been available in 50 mg oral powder and 250 mg tablets. The new formulation of 625 mg reduces the pill burden from five 250 mg tablets twice a day to two 625 mg tablets twice a day, potentially facilitating adherence to treatment regimens. Viracept is a protease inhibitor indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. The 250 mg tablet and oral powder received marketing approval in 1997 based on substantive evidence of efficacy and safety. Results of the bioequivalence study of the 250 mg tablet and the 625 mg tablet revealed increased bioavailability with the 625 mg tablet.
The sponsor, Agouron Pharmaceuticals, has submitted clinical safety and pharmacokinetic data to FDA providing evidence that the higher exposures do not pose a safety risk. However, diarrhea may be more common in patients receiving the 625 mg formulation. No efficacy information is contained in this submission because it is unlikely that a more bioavailable formulation would be less efficacious.
Labeling rule proposed for dietary supplements
The FDA has proposed a new regulation requiring current good manufacturing practices in the manufacturing of unadulterated dietary supplements. The proposed rule would attempt to ensure that dietary supplements and dietary ingredients are not adulterated with contaminants or impurities and are labeled to accurately reflect the active ingredients.
The rule includes requirements for designing and constructing physical plants, establishing quality control procedures, and testing manufactured dietary ingredients and supplements. It also includes proposed requirements for maintaining records and for handling consumer complaints. In recent years, analyses of dietary supplements by a private-sector laboratory suggested that a substantial number of products analyzed may not contain the amounts of dietary ingredients identified on the product labels. For example:
- Five of 18 soy- and/or red clover-containing products were found to contain only 50% to 80% of the declared amounts of isoflavones.
- Of 25 probiotic products tested, eight contained less than 1% of the claimed number of live bacteria or the number of bacteria that would be expected to be found in such a product.
The FDA also has encountered products being marketed that are not accurately labeled or contain contaminants that should not be present or may be harmful. For example:
- One firm recalled dietary supplements contaminated with excessive amounts of lead, which may have posed a health risk to many consumers, especially children and women of childbearing age.
- Another firm recalled a niacin product after it received reports of nausea, vomiting, liver damage, and heart attack associated with the use of the product. A dietary ingredient manufacturing firm had mislabeled a bulk ingredient container that subsequently was used by another firm in making a product that contained almost 10 times more niacin than the amount that may be safe.
- Another firm recalled its product after it was found that a dietary supplement containing folic acid, which is often taken by women to reduce the risk of having a baby with neural tube defects, contained only 35% of the amount of folic acid claimed on the label.
Under the proposal, manufacturers would be required to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, the FDA would consider those products to be adulterated.
The rule is intended to cover all types of dietary supplements. However, to limit any disruption for dietary supplements produced by small businesses, the FDA is proposing a three-year phase-in of a final rule for small businesses. The proposal includes flexible standards that can evolve with improvements in the state of science, such as in validating tests for identity, purity, quality, strength, and composition of dietary ingredients.
Information, including the proposed rule, may be found on the FDA’s web site:
- Fact Sheet. http://www.fda.gov/bbs/topics/NEWS/dietarysupp/factsheet.html.
- Backgrounder. http://www.fda.gov/bbs/topics/NEWS/dietarysupp/background.html.
- Proposed Rule. (PDF 89.5 MB) www.fda.gov/OHRMS/DOCKETS/98fr/96n-0417-npr0001-01.pdf.
FDA completes first phase of Drugs@FDA
The FDA recently completed the first phase of Drugs@FDA: A Catalog of FDA-Approved Drug Products. This pilot project is designed to be a searchable Internet source for official information about FDA-approved brand name and generic drugs, including those for the treatment of HIV/AIDS and related conditions.
Prescription, over-the-counter, and discontinued drugs are included in the database. Links are provided to access approval letters, labels, and scientific reviews. The majority of labels, approval letters, reviews, and other information are available for drug products approved from 1998 to the present. The first phase ended May 21, and the next phase of the project will be announced this summer.
For more information, go to: www.fda.gov/.
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