FDA Notifications: FDA's meeting of Antiviral Drugs Advisory Committee
FDA's meeting of Antiviral Drugs Advisory Committee
The FDA will hold a public meeting of its Antiviral Drugs Advisory Committee on Oct. 19 and 20, 2006, to discuss design issues in the development of products for treatment of chronic hepatitis C, including co-infection with HIV.
The meeting will be held on Oct. 19, 2006, from 8 a.m. to 4 p.m. and on Oct. 20, 2006, from 8 a.m. to 4 p.m. at the Hilton Washington DC/Silver Spring, 8727 Colesville Road, Silver Spring, MD, 20910 in The Ballrooms. Please note that meeting will be closed to the public on Oct. 20 from 1 p.m. to 4 p.m., to permit discussion and review of trade secret and/or confidential information.
On both days, the committee will discuss clinical trial design issues in the development of products for the treatment of chronic hepatitis C infection. This meeting is being convened in response to the growing number of products in development for this indication. The primary objectives for committee deliberations are to discuss issues related to the identification of appropriate control arms, populations for study, end points, and long-term follow-up. As noted above, on Oct. 20, 2006, the meeting will be open to the public from 8 a.m. to 12 noon, unless public participation does not last that long, and closed to the public from 1 - 4 p.m.
Background material will become available no later than 1 business day before the meeting and will be posted on FDA's Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year "2006" and scroll down to the Antiviral Drugs Advisory Committee meeting.)
Interested parties may submit comments electronically on line at: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Select "2006N-0219--Clinical Trial" and follow the prompts to submit your statement.
Written comments may be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, by close of business on Oct. 5, 2006.
All comments received will be posted without change, including any personal information provided. Comments received on or before Oct. 5, 2006, will be provided to committee members before the meeting.
Oral presentations from the public (the open public hearing section of the meeting) will be scheduled between approximately 1 p.m. and 2 p.m. on Oct. 19, 2006. Time allotted for each presentation may be limited depending on the number of requests to speak. Those desiring to make formal oral presentations should notify the contact person (below) on or before Oct. 5, 2006, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the name(s) and contact information of the proposed speaker(s), and an indication of the approximate time requested to make their presentation.
Contact Person: Cicely Reese, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: [email protected]
For up-to-date information about the meeting, please use the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and enter code no. 3014512531.
No registration is necessary
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Cicely Reese at least 7 days in advance of the meeting.
Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. If you need hotel accommodations or directions, please contact the hotel directly at 301-589-5200.
FDA grants tentative approval for stavudine capsules under PEPFAR
On Aug. 28, 2006, the FDA granted tentative approval for stavudine capsules, 30 mg and 40 mg, manufactured by Strides Arcolab Ltd., Bangalore, India, under the expedited review provisions created for the President's Emergency Plan for AIDS Relief (PEPFAR).
The FDA's tentative approval means that although the product meets all of the safety, efficacy, and manufacturing quality standards required for marketing in the U.S., existing patents and/or exclusivity currently prevent marketing of this product in the United States. Tentative approval, however, qualifies the product for consideration for purchase under the PEPFAR program.
As with all generic applications, 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 to 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.
This product is a generic version of Zerit Capsules, 30 mg and 40 mg, a nucleoside reverse transcriptase inhibitor used in combination with other antiretroviral agents for the treatment of HIV-1 infection, manufactured by Bristol-Myers Squibb.
FDA approves generic formulation of nevirapine
The FDA granted tentative approval on Aug. 11, 2006, for Nevirapine tablets, 200 mg, manufactured by Strides Arcolab Ltd., Bangalore, India. This action represents the first product manufactured by Strides Arcolab to receive tentative approval for a generic formulation of a therapy for HIV/AIDS from the FDA. It is, however, the fourth generic formulation of Nevirapine to receive tentative approval from FDA under the expedited review provisions created for PEPFAR.
The FDA's tentative approval means that although existing patents and/or exclusivity prevent marketing of this product in the United States, the product meets all of the safety, efficacy, and manufacturing quality standards required for marketing in the U.S., and can be considered for purchase under PEPFAR.
As with all generic applications, 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 to 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.
This product is a generic version of Viramune tablets manufactured by Boehringer Ingelheim, a non-nucleoside reverse transcriptase inhibitor used in combination with other antiretroviral agents for the treatment of HIV-1 infection.
The use of single dose of nevirapine for the prevention of mother-to-child transmission of HIV is permitted under PEPFAR.
FDA grants tentative approval to lamivudine/zidovudine fixed dose tablet
The FDA, on Sept. 13, 2006, granted tentative approval for a fixed dose tablet containing lamivudine/zidovudine 150 mg/300 mg, manufactured by Cipla Limited of Mumbai, India. The tablets are indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
Tentative approval means that the FDA has concluded that a drug product has met all of the required quality, safety and efficacy standards, though it may not be marketed in the U.S. due to existing patents and/or exclusivity rights. However, tentative approval makes the product eligible to be considered for purchase under the PEPFAR program.
The FDA will hold a public meeting of its Antiviral Drugs Advisory Committee on Oct. 19 and 20, 2006, to discuss design issues in the development of products for treatment of chronic hepatitis C, including co-infection with HIV.Subscribe Now for Access
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