1995 | 1996 | 1997 | 1998
- On February 8, FDA approved Mepron (atovaquone) for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in patients who are intolerant to trimethoprim-sulfamethoxazole (TMP-SMX).
- On February 23, FDA revised the guidance for Home Specimen Collection Kit Systems Intended for Human Immunodeficiency Virus (HIV-1 and/or HIV-2) Antibody Testing.
- On March 24, FDA cleared for marketing the first blood test to measure latex antibodies in the blood. The test can be used to help identify people who are allergic to latex and as such assist people in the use of barrier products to prevent HIV transmission.
- On April 14, FDA approved Chartex International plc. London, U.K. premarket approval application for the Femidom Female Condom. The product is an intravaginal barrier device and is indicated for use to help prevent pregnancy, which will be used as an indicator of the device's performance in preventing STDs.
- In June 1995, FDA published "An FDA Guide To Choosing Medical Treatments," FDA Consumer.
- In June 1995, FDA allowed the initiation of an open label study for saquinavir for the treatment of HIV infection and AIDS. Saquinavir, manufactured by Hoffmann-La Roche, is the first protease inhibitor made available outside of ongoing clinical trials.
- On June 6, FDA revised the blood donor criteria to exclude prisoners from donating blood, blood components and plasma for 12 months from the last date of incarceration.
- On June 16, FDA approved Foscavir (foscarnet) for the treatment of acyclovir-resistant herpes simplex virus.
- August 1995, FDA recommended that blood establishments should implement donor screening for HIV-1 antigen using licensed test kits. Although, currently there are no tests for HIV-1 antigen(s) approved for donor screening, FDA issued the recommendation on HIV-1 in advance of the availability of such test in order to provide blood and plasma establishments with maximum time to prepare for this testing.
- On September 1, FDA authorized pre-approval distribution of intravenous cidofovir (Vistide) under a treatment IND protocol for HIV-infected persons relapsing cytomegalovirus (CMV) retinitis that has progressed despite treatment.
- On September 8, FDA published in the Federal Register a proposed rule to amend its regulations pertaining to investigational new drug applications (INDs) and new drug applications (NDAs). The proposed rule is responsive to one of the recommendations made by the National Task Force on AIDS Drug Development. The proposed rule would clearly define in the NDA format and content requirements the need to present effectiveness and safety data for important demographic subgroups, specifically gender, age, and racial subgroups.
- On October 12, FDA approved Biaxin (clarithromycin) for the prevention of Mycobacterium avium complex (MAC).
- On October 27, FDA granted marketing approval for Cytovene capsules (oral ganciclovir) as a prophylactic treatment for the prevention of HIV-related cytomegalovirus (CMV) disease.
- On November 17, FDA approved Doxil (doxorubicin HCL liposome injection) for the treatment of Kaposi's Sarcoma.
- On November 20, FDA granted accelerated approval for Epivir (lamivudine, 3TC) for use in combination with Retrovir (zidovudine, AZT) in treating AIDS and HIV infection.
- On November 20, FDA approved Abelcet (amphotericin B lipid complex) for the treatment of aspergillosis.
- On December 6, FDA approved Invirase (saquinavir) the first protease inhibitor, for use in combination with other nucleoside analogue medications. This application received approval only 97 days after FDA received the application for marketing.
- On December 12, FDA released a report, "Timely Access to New Drugs in the 1990s"An International Comparison," which documents FDA's tough standards do not delay consumer access to important new drugs, compared to other countries and that the United States has available valuable drugs as soon as, and in many cases sooner than, its counterparts around the world. The average U.S. approval time for antiretroviral agents was approximately six months.
- On December 21, FDA granted traditional approval for Zerit (stavudine, d4T) for the treatment of HIV infected adults who have received prolonged prior AZT therapy. Zerit had previously been approved under the accelerated approval regulations.
- On March 1, FDA granted full approval for Norvir (ritonavir) for use alone or in combination with nucleoside analogue medications in people with advanced HIV disease. Norvir also received accelerated approval for less advanced HIV disease.
- On March 4, FDA granted full approval for Vitrasert (intravitreal implant with Cytovene (ganciclovir) for the treatment of CMV Retinitis.
- On March 13, FDA granted accelerated approval for Crixivan (indinavir) for use alone or in combination with nucleoside analogue medications in people with HIV or AIDS. FDA approved the drug in just 42 days after receiving its application for marketing.
- On March 14, FDA approved the first antigen test kit, Coulter HIV-1 p24 Antigen Assay, to screen blood donors for HIV-1. It has been estimated that HIV-1 antigen screening could prevent approximately 5-10 cases per year or up to 25 percent of current cases of HIV infection transmitted by transfusion.
- On April 8, FDA granted full approval for DaunoXome (daunorubicin citrate lipsome injection) for first line cytotoxic treatment of advanced, HIV-associated Kaposi's Sarcoma
- On May 14, FDA approved the first HIV test system that can be used at home and can be purchased over-the-counter (OTC). The
- Confide HIV Testing System, developed by Direct Access Diagnostics, is comprised of three integrated components: an OTC home blood collection kit, HIV-antibody testing at a certified lab, and a test result center that provides test results, counseling and referral anonymously.
- On June 3, FDA approved Amplicor HIV-1 Monitor Test, an in vitro nucleic acid amplification test for the quantitation of HIV-1 RNA in human plasma. The test is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis.
- On June 3, FDA approved the HIV-1 western blot confirmatory test for OraSure's oral collection system. The oral collection system was originally approved in 1994 using an enzyme-linked immunosorbent assay (ELISA)method.
- On June 12, FDA approved Zithromax (azithromycin) for preventing or delaying the onset of infection with mycobacterium avium complex (MAC).
- On June 21, FDA granted accelerated approval for Viramune (nevirapine) for use in combination with nucleoside analogues to treat adults with HIV infection who have experienced clinical and/or immunological deterioration.
- On June, 26, FDA approved Vistide (cidofovir) as an intravenous treatment for AIDS-related CMV retinitis, a potentially severe eye infection that can lead to blindness.
- On July 17, FDA issues a letter to health care providers regarding approximately 15 case reports of spontaneous bleeding episodes in HIV positive patients with hemophilia who were being treated with HIV protease inhibitors at the time of the event.
- On August 6, FDA approved the first HIV test which uses urine samples. The urine-based test detects the presence of antibodies to HIV-1 using an enzyme-linked immunosorbent assay (ELISA) method.
- On August 23, FDA approved Serostim (somatropin rDNA origin for injection) for treatment of AIDS wasting and cachexia.
- On February 21, FDA approved a supplemental indication for Sporanox (itraconazole) for the treatment of oropharyngeal and esoplogeal candidiasis.
- On March 14, FDA granted accelerated approval for Viracept (nelfinavir) the first protease inhibitor labeled for use in children, as well as adults.
- On March 14, FDA approved pediatric labeling for the protease inhibitor Norvir (ritonavir).
- On April 4, FDA granted accelerated approval for Resciptor (delavirdine), a non-nucleoside reverse transcriptase inhibitor (NNRTI), for use in combination with other antiretroviral drugs for the treatment of HIV-1.
- On June 11, FDA issued a Public Health Advisory regarding reports of diabetes and hyperglycemia in patients receiving protease inhibitors for the treatment of HIV-1.
- On August 4, FDA approved Taxol (paclitaxel) for second line treatment of AIDS-related Karposi's Sarcoma.
- On September 17, FDA approved Famvir (famciclovir) for the suppression of recurrent episodes of genital herpes in immunocompetent adults.
- On September 26, FDA approved Combivir, a combined form of AZT and 3TC, two previously approved antiretroviral drugs for the treatment of HIV-1.
- On September 26, FDA warns consumers and pharmacists about two unapproved, fraudulently marketed home-use test kits which were advertised on the Internet for home HIV and Hepatitis A testing.
- On September 26, FDA issued a final rule requiring labeling of latex condoms to contain an expiration date based upon physical and mechanical testing performed after exposing the product to varying conditions that age latex.
- On November 7, FDA approved Fortovase, a new formulation of Invirase (saquinavir) for the treatment of HIV-1.
- On January 8, 1998, FDA approved Glyde Dam Lollyes (Glyde USA, Inc., Redmond, WA 98052-4712) designed as a barrier for use while performing cunnilingus. When properly used, it may help reduce the risk of catching or spreading many Sexually Transmitted Diseases (STDs) such as syphilis, gonorrhea, chlamydia infections, gential herpes and HIV; however, it cannot eliminate the risk.
- On February 27, FDA cosponsored a 2 hour satellite broadcast from its television studio discussing the Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents.
- On May 6, 1998, FDA approved a virally inactivated, processed blood product (SD Plasma) manufactured from pooled human plasma that can serve as an alternative to fresh frozen plasma. The manufacturing process for this new product includes a solvent detergent procedure that inactivates some blood-borne viruses such as HIV.
- On May 28, 1998, FDA approved Cambridge Biotech HIV-1, a Human Immunodeficiency virus Type 1 (Western Blot) test with a new indication for urine specimen testing.
- On June 12, 1998, FDA approved Famvir (famciclovir/SmithKline Beechman) for the additional indication for the treatment of recurrent mucocutaneous herpes simplex infections in HIV-infected patients at a dose of 500 mg twice daily.
- On July 22, 1998 FDA cosponsored a 2 hour satellite broadcast from its television studios discussing the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
- On July 23, 1998, FDA issues guidance to manufacturers of Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions (pdf file)
- On August 26, 1998, FDA approved Vitravene Injection (fomivirsen sodium intravitreal injectable), Isis Pharmaceuticals, for the local treatment of cytomegalovirus (CMV) retinitis in patient with acquired immunodeficiency syndrome (AIDS) who are intolerant of or have a contraindication to other treatment(s) for CMV retinitis or who were insufficiently responsive to previous treatment(s) for CMV retinitis.
Approval Letter and Labeling.
- On September 17, 1998, FDA approved Sustiva (efavirenz), DuPont Pharmaceuticals, to treat HIV and AIDS.
Sustiva Consumer Information
- Ziagen (abacavir), Glaxo Wellcome, received accelerated approval on December 17, 1998 to treat HIV-1 in adults and children.
- Panretin (alitretinoin) gel 0.1% was approved on February 2, 1999 for the topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma. The manufacturer is Ligand Pharmaceuticals.
- Glass Capillary Tubes: Joint Safety Advisory About Potential Risks, February 1999. This document discusses the potential risk of injury and/or infection from bloodborne pathogens, including HIV, hepatitis B and hepatitis C viruses, due to the accidental breakage of glass capillary tubes, and to recommend certain steps that can minimize the risk.
- On March 2, 1999, FDA approved a supplement to AMPLICOR HIV-1 MONITOR Test (Roche Molecular Systems, Inc.). This supplemental approval extends the lower limit of quantitation from 400 HIV RNA copies/mL down to 50 copies/mL; the upper limit of quantitation, 750,000 HIV RNA copies/mL remains the same. It is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. On the same date, another supplement was approved for patient monitoring and it can be used as an aid in management of patients on anti-viral therapy for HIV disease. The original application, approved June 3, 1996, was for disease prognosis in conjunction with clinical presentation and other laboratory markers. (Labeling, 53 pages in PDF)
- Ozone Generator Sentencing - On March 29, 1999, Kenneth Thiefault and his wife Mardol Barber were sentenced in a Florida court for their conviction last year on conspiracy, distribution of an ozone generator, mail fraud, wire fraud, and tax violations. The court sentenced Mr. Thiefault to 72 months of incarceration (to be followed by 3 years of supervised release), imposed a $100,000 fine, and ordered payment of $14,400 in restitution. The court sentenced the Ms. Barber to 33 months of incarceration (to be followed by 3 years of supervised release) and imposed a fine of $60,000. Additionally, the court ordered both defendants to help the IRS compute their back taxes and banned both defendants from participating in any securities or telemarketing businesses in the future. The couple were making claims that the ozone generators can oxidize toxins in the body and cure everything from gangrene to cancer to AIDS.
- Agenerase (amprenavir, Glaxo Wellcome, Inc.) 50 mg, 150 mg capsules and oral solution received accelerated approval on April 15, 1999. Agenerase is a protease inhibitor that is indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV RNA levels and CD4 cell counts in controlled studies of up to 24 weeks in duration. At present, there are no results from controlled trials evaluating long-term suppression of HIV RNA or disease progression with Agenerase.