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FDA issues final guidance on human cell, tissue donations
The FDA has issued final guidance, entitled "Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)," to assist establishments making donor eligibility determinations to comply with the requirements for determining donor-eligibility, including donor screening and testing for donors of human cells, tissues, and cellular and tissue-based products. (For background, see www.fda.gov)
The guidance applies to cells and tissues procured on or after the effective date of the regulations contained in 21 CFR part 1271, subpart C (effective date May 25, 2005). It does not replace the guidance concerning 21 CFR part 1270, entitled "Guidance for Industry: Screening and Testing of Donors of Human Tissue Intended for Transplantation," which remains applicable to tissues recovered before May 25, 2005, and subject to 21 CFR part 1270.
The document provides guidance on donor-eligibility determination, donor screenings, donor testing requirements (including HIV), additional screening and testing requirements for reproductive cells and tissues, and exceptions from the requirements for determining donor-eligibility, and special circumstances.
The complete guidance document is available on the FDA web site at www.fda.gov.
FDA grants approval for generic didanosine for oral solution
On March 8, 2007, the FDA granted approval for generic didanosine for oral solution (Pediatric Powder), 10 mg/mL, packaged in 2-gram and 4-gram containers, manufactured by Aurobindo Pharma Limited, of Hyderabad, India, allowing marketing in United States.
This is a generic version of the already FDA-approved Videx Pediatric Powder for Oral Solution, 10 mg/mL, manufactured by Bristol Myers Squibb.
FDA granted tentative approval for this product on Oct. 5, 2006, permitting purchase of this generic formulation of didanosine by the President's Emergency Plan for AIDS Relief, or PEPFAR. A tentative approval means that a drug product has met FDA's safety, efficacy and quality standards, but is ineligible for marketing in the U.S. until patent and/or exclusivity restrictions expire.
However, because patents and exclusivity for Videx For Oral Solution have expired (see FDA's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book"), the generic formulation can be granted approval, allowing it to be marketed in the United States.
Didanosine for oral solution is approved for use in combination with other antiretroviral agents in the treatment of HIV infection.
The PEPFAR program was created to provide government funding to treat, and reduce transmission of HIV in 15 focus countries, mostly in Sub-Saharan Africa, but including Haiti, Guyana, and Vietnam.
Because drugs that do not conform to standards of potency, purity, stability, or good manufacturing procedures may pose a threat by increasing chance of substandard performance, treatment failure, and emergence of resistant virus, PEPFAR limits funding to acquire only products that have undergone stringent regulatory review.
While FDA does not approve drugs for use in other countries, the agency has expedited review procedures in place (and conducts inspections of the manufacture and testing sites) to determine whether the drug products meet FDA safety, efficacy, and manufacturing quality standards, thus making them eligible for purchase using PEPFAR funds.
When the determination is made that a product meets the required criteria and standards, FDA may issue a "tentative approval," even though the product cannot yet be marketed in the United States because of legal restrictions related to existing exclusivity rights held by the original drug manufacturer. Once marketing exclusivities expire, the FDA can grant marketing approval of the generic formulation in the U.S. market.
Since the time didanosine for oral solution received a tentative approval in October, 2006, allowing it to be purchased through PEPFAR (for use in PEPFAR-affected countries), expiration of patents has resulted in an approval that now allows marketing of this generic formulation of didanosine for oral solution in the United States.
FDA tentatively approves generic stavudine
The Food and Drug Administration (FDA) granted tentative approval on April 23, 2007, for a generic formulation for stavudine capsules, 30 mg and 40 mg, manufactured by Matrix Laboratories Limited of Hyderabad, India, under expedited review provisions developed for the President's Emergency Plan for AIDS Relief (PEPFAR).
"Tentative Approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, even though it may not yet be marketed in the U.S. because of existing patents and/or exclusivity rights. However, tentative approval does make the product eligible 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 is a generic formulation of the already approved Zerit brand capsules, 30 mg and 40 mg, made by Bristol Myers Squibb, which is protected by existing patent and pediatric exclusivity rights. Effective patent dates are listed in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book"
Stavudine is a nucleoside reverse transcriptase inhibitors (NRTI) indicated for used in combination with other antiretroviral agents in the treatment of HIV infection.
Kaletra product labeling is updated
Product labeling for Kaletra (lopinavir/ritonavir) has been updated to reflect safety and efficacy data from study M97-720 in treatment-naïve patients out to 360 weeks. Kaletra is manufactured by Abbott Laboratories, North Chicago, IL.
FDA tentatively approves generic abacavir
The Food and Drug Administration, on April 5, 2007, granted tentative approval for abacavir sulfate tablets, 300 mg, manufactured by Matrix Laboratories, Inc., of Hyderabad, India, under expedited review provisions developed for the President's Emergency Plan for AIDS Relief (PEPFAR).
This is a generic version of the already-approved Ziagen brand of the product manufactured by GlaxoSmithKline, which is protected under patent and pediatric exclusivity, which are listed in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book"
"Tentative Approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, though it may not yet be marketed in the U.S. because of existing patents and/or exclusivity rights. However, tentative approval does make the product eligible for consideration for purchase under the PEPFAR program.
Abacavir sulfate is a member of the class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs), which help keep the AIDS virus from reproducing. This antiretroviral drug is intended to be used in combination with other antiretroviral agents for the treatment of HIV-1 infection.