FDA Notifications
Generic lamivudine/zidovudine approved
On May 29, 2009, the Food and Drug Administration (FDA) granted tentative approval for generic lamivudine/zidovudine tablets 150 mg/300 mg indicated for treatment for Human Immunodeficiency Virus (HIV) in patients with or without Acquired Immunodeficiency Syndrome (AIDS).
Tentative approval means that FDA has concluded that a drug product has met all of the required quality, safety and efficacy standards, but that it cannot be marketed in the U.S. due to existing patents rights. However, tentative approval makes the product eligible to be considered for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR) program. Existing patent information is available in the FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
The FDA conducts an on-site inspection of each manufacturing facility and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval of these applications to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.
A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan can be found on the FDA website.
The lamivudine/zidovudine fixed dose combination tablets are a version of the FDA approved Combivir tablets manufactured by GlaxoSmithKline.
Testosterone gel must include warning for kids
The Food and Drug Administration is requiring manufacturers of two prescription topical testosterone gel products, AndroGel® 1% and Testim® 1%, to include a boxed warning on the products' labels after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with a person being treated with these products (secondary exposure).
The gels are approved for use in men who either no longer produce testosterone or produce it in very low amounts, and are often used by men living with HIV who have below normal testosterone levels.
Although the Precautions in the current labels instruct users to wash their hands after using the product and to cover the treated skin with clothing, FDA has received reports of secondary exposure to testosterone in children ranging in age from nine months to five years. In most of the cases, users of these products failed to follow appropriate use instructions, resulting in direct contact between treated skin and the child.
Adverse events reported in these children included inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior. In most cases, the signs and symptoms regressed when the child no longer was exposed to the product. In some cases, however, enlarged genitalia did not fully return to age-appropriate size and bone age remained modestly greater than the child's chronological age. In some cases, invasive diagnostic procedures were required.
Signs of inappropriate virilization (development of male secondary sexual characteristics) in children and the possibility of secondary testosterone exposure should be brought to a health care provider's attention.
The required label changes will provide additional information about the risk of secondary exposure and the steps that should be taken to reduce this risk. The FDA also is requiring that the manufacturers of these products develop a Medication Guide as part of a Risk Evaluation and Mitigation Strategy to ensure that the benefits of these products continue to outweigh their potential risks. The FDA recommends the following precautions be taken to minimize the potential for secondary exposure:
- Adults who use testosterone gels should wash their hands with soap and warm water after every application;
- Adults should cover the application site with clothing once the gel has dried;
- Adults should wash the application site thoroughly with soap and warm water prior to any situation where skin-to-skin contact with another person is anticipated;
- Children and women should avoid contact with testosterone application sites on the skin of men who use these products; and
- Adults should note that use of any similar, but unapproved, products from the marketplace –including the Internet– that can result in the same serious adverse effects should be avoided.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of these gels to the FDA's MedWatch Adverse Event Reporting program: Online: www.fda.gov/MedWatch/report.htm or by fax at (800) FDA-0178 or telephone at (800) FDA-1088 or by regular mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.AndroGel 1% is manufactured by Marietta, Ga.-based Solvay Pharmaceuticals. Testim 1% is made by Auxilium Pharmaceuticals, Malvern, PA.
Lamivudine/zidovudine tab tentatively approved
On May 7, 2009, using expedited review procedures developed to support the President's Emergency Program For AIDS Relief (PEPFAR), FDA granted tentative approval for lamivudine/zidovudine fixed dose combination tablets, 150 mg/300 mg, co-packaged with nevirapine tablets, 200 mg. The product, indicated for use alone as a complete regimen, or in combination with other antiretroviral agents for the treatment of HIV-1 infection, is manufactured by Hetero Drugs Limited of Hyberdad, India. Both lamivudine and zidovudine are members of the Nucleoside Reverse Transcriptase Inhibitor (NRTI) class of antivirals. Nevirapine is a Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI).
Fixed dose combination and co-packaged products such as this can help ease pill burden and simplify therapy, and may help increase adherence to therapeutic regimens, potentially reducing development of resistance to the separate drugs.
On May 29, 2009, the Food and Drug Administration (FDA) granted tentative approval for generic lamivudine/zidovudine tablets 150 mg/300 mg indicated for treatment for Human Immunodeficiency Virus (HIV) in patients with or without Acquired Immunodeficiency Syndrome (AIDS).Subscribe Now for Access
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