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For Consumers

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What's New at FDA in HIV/AIDS

Late breaking information, as well as an archival record of updates on safety and regulatory issues related to HIV/AIDS, dating from 2002 to present. Information includes

product approvals
significant labeling changes
safety warnings
notices of upcoming public meetings
notices about proposed regulatory guidances

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2009

November 06, 2009 Tentative approval of lamivudine and tenofovir df fixed dose combination tablets, 300mg/300mg
September 29, 2009 FDA licensing of donor screening test for antibodies to HIV type 1, groups M and O, and HIV type 2
September 04, 2009 Tentative approval of efavirenz, lamivudine, and tenofovir disoproxil fumarate tablets, 600mg/300mg/300mg
August 31, 2009 New Guidelines for Prevention and Treatment of Opportunistic Infections among HIV-Exposed and HIV-Infected Children
August 26, 2009 New Intelence labeling: severe skin and hypersensitivity reactions
August 13, 2009 Tentative approval of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate
August 12, 2009 New Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs
August 07, 2009 Tentative approval of generic lamivudine tablets, 150 mg and 300 mg
August 04, 2009 Tentative approval of generic efavirenz capsules
July 23, 2009 Approval of zidovudine 60 mg tablets for pediatric dosing
July 23, 2009 Tentative approval of fixed dose combination of lamivudine/zidovudine tablets for pediatric dosing
July 16, 2009 Tentative approval of stavudine/lamivudine/nevirapine fixed dose combination tablets
July 15, 2009 Tentative approval of generic abacavir/lamivudine/zidovudine fixed-dose combination tablet
July 09, 2009 Isentress (raltegravir) indication extended for the treatment of HIV-1 infection in treatment-naïve patients
June 27, 2009 Take the Test / Take Control: National HIV testing Day
June 23, 2009 Tentative approval of lamivudine tablets, 150 mg and 300 mg
June 19, 2009 Important changes to Videx (didanosine) labeling
June 01, 2009 Tentative approval of lamivudine/zidovudine tablets 150 mg/300 mg fixed dose combination
May 18, 2009 Safety concerns prompt label changes and Medication Guide requirement for Testosterone Gel Products
May 12, 2009 Tenative approval of lamivudine/zidovudine fixed dose combination tablets plus nevirapine tablets
May 01, 2009 Important update about Emergency Use Allowance for use of Tamiflu and Relenza
May 01, 2009 Swine Influenza (H1N1) and Adults and Adolescents infectedwith HIV: Considerations for Clinicians
April 30, 2009 Tentative approval, tenofovir disoproxil fumarate tablets, 300 mg
April 21, 2009 Kaletra labeling changes approved
April 06, 2009 Act Against AIDS, a new CDC campaign to raise AIDS awareness
April 06, 2009 Labeling changes for Kaletra reflecting new QT/QTC interval and PR interval prolongation information
April 01, 2009 Tentaive approval of generic nevirapine tablets, 200 mg
March 31, 2009 Tentative approval of abacavir sulfate and lamivudine tablets, 600 mg (base)/300 mg
March 31, 2009 Tentative approval emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg
March 23, 2009 Approval of generic stavudine for oral solution, 1 mg/mL
March 19, 2009 Tentative approval of stavudine and lamivudine fixed dose combination tablets
March 17, 2009 Tentative approval of lamivudine Tablets, 150 mg
March 11, 2009 Tentative approval of lopinavir/ritonavir tablets , 200 mg/50 mg
March 09, 2009 FDA approval of the FC2 Female Condom
March 03, 2009 Tentative approval of stavudine, lamivudine and nevirapine fixed dose combination tablets
February 20, 2009 Important notice for people with impaired immune function about peanut products recalled for Salmonella
February 19, 2009 Tentative approval of tenofovir disoproxil fumarate tablets, 300 mg
February 05, 2009 Traditional approval of Isentress (raltegravir)
March 23, 2009 Approval of generic stavudine for oral solution, 1 mg/mL
January 08, 2009 Approval of generic stavudine capsules 30 mg and 40 mg

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2008

12/31/2008 FDA approval of NAT for detection of HIV-2, HIV-1 Groups O and M, and Hepatitis B and C
12/30/2008 FDA approval of three generic stavudine formulations
12/19/2008 Ziagen 300 mg scored tablet facilitates pediatric treatment of infection with HIV
12/19/2008 Tentative approval of abacavir sulfate and lamivudine fixed-dose combination
12/19/2008 New 75 mg Prezista tablet and corresponding pediatric dosing information approved
12/14/2008 PEPFAR-related tentative approval of generic efavirenz
12/09/2008 FDA Obstetrics and Gynecology Devices Panel meeting to consider FC2 Female Condom
12/04/2008 Traditional approval and label changes for Selzentry (maraviroc)
11/16/2008 Final Rule: Latex condom labeling
11/04/2008 Revised Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
10/22/2008 Traditional approval of Prezista (darunavir), a new dosing regimen for treatment-naïve patients, new 400 mg tablets, and revised Pregnancy Category
10/08/2008 Tentative approval for a generic formulation of lamivudine 150 mg and 300 mg tablets
10/02/2008 Alternative dosing regimen for Reyataz (atazanavir) for treatment-naïve patients who can take ritonavir
09/29/2008 Videx EC labeling changes with pediatric dosing information added
09/25/2008 Approval of generic didanosine delayed release capsules, 125 mg, 200 mg, 250 mg, and 400 mg
09/22/2008 Retrovir syrup, capsules and tablets label update for twice daily dosing in children 6 weeks to 18 years of age
09/14/2008 Tentative approval of abacavir sulfate 60 mg scored tablet for pediatric dosing
09/03/2008 Tentative approval of abacavir sulfate and lamivudine tablets, 600 mg/300 mg
09/02/2008 Updated labeling for Norvir (ritonavir) soft capsule and oral solution
08/21/2008 Important updates to the Reyataz (atazanvir) label
08/07/2008 Revised Pediatric Treatment Guidelines
07/23/2008 Important safety-related label update for Ziagen (abacavir sulfate)
06/27/2008 Zidovudine Oral Solution USP, 50 mg/5 mL generic product approval
06/27/2008 Important changes to Viramune (nevirapine) oral solution and tablets
06/23/2008 New pediatric dosing for Aptivus, patients 2-18 years, New Oral Solution and info on coadministration with midazolam
06/23/2008 New pediatric dosing information for Kaletra, patients 14 days to 6 months and 12-18 years of age and update information on coadministration with midazolam
06/20/2008 Tentative approval: Fixed dose combination of generic lamivudine/stavudine tablets for pediatric dosing
06/20/2008 Report of false-positive oral fluid rapid HIV test results
06/11/2008 Recent updates to Invirase package insert
05/21/2008 Tentative approval of generic emtricitabine capsules
05/16/2008 Tentative approval of generic nevirapine tablets
03/28/2008 Approval of VITROS Anti-HIV 1+2 diagnostic immunoassay
03/27/2008 Early Communication about an Ongoing Safety Review of Ziagen (Abacavir) and Videx (Didanosine)
03/26/2008 New pediatric dosing recommendations for Reyataz Capsules, patients ages 6 to 18 years old
03/24/2008 Tentative approval of two fixed dose combination products for PEPFAR
03/12/2008 Dear Healthcare Professional letter regarding new prescribing information for Prezista (darunavir)
03/11/2008 Updates to Prezista (darunavir) tablets labeling
02/26/2008 New 600 mg tablet strength for Prezista (darunavir)
02/14/2008 Approval of generic zidovudine tablets, 300 mg
02/08/2008 Tentative approval of generic atazanavir sulfate capsules
02/07/2008 New Epivir tablets to facilitate pediatric dosing
01/29/2008 Tentative approval of generic lamivudine
01/29/2008 Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents updated
01/18/2008 Approval of etravirine for treatment-experienced adult patients
01/16/2008 Reyataz (atazanavir) package insert revisions

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2007

12/20/2007 Tentative approval of generic formulation of efavirenz
12/20/2007 Labeling update for Lexiva ((fosamprenavir)
12/18/2007 New Warning for Nonoxynol 9 OTC Contraceptive Products re: STDs and HIV/AIDS
12/17/2007 Updated information regarding antiretroviral agents used as HIV postexposure prophylaxis for occupational HIV exposures
12/14/2007 FDA proposes requirements for human blood and blood components intended for transfusion or further manufacturing use
11/30/2007 Tentative approval for a generic version of Tenofovir Disoproxil Fumarate Tablets
11/30/2007 Tentative approval of generic combination of lamivudine/zidovudine tablets
11/09/2007 A new half-strength Kaletra formulation approved
11/05/2007 Final Guidance: The Role of HIV Resistance Testing in Antiretroviral Drug Development
11/05/2007 Tentative approval of lamivudine/stavudine fixed dose combination
11/01/2007 Tentative approval of staudine for oral solution
10/12/2007 New dosing regimen for Lexiva approved
10/12/2007 FDA approval of Isentress (raltegravir)
10/11/2007 Traditional approval of Aptivus (tipranavir)
09/10/2007 Important information about Viracept
08/14/2007 Tentative approval of new triple fixed dose combination tablet of lamivudine, stavudine and nevirapine
08/13/2007 Important Dear Healthcare Provider letter about pediatric dosing
08/13/2007 Tentative approval of generic nevirapine
08/09/2007 Tentative approval of generic lamuvidine and zidovudine combination tablets
08/06/2007 Approval of Maraviroc, CCR-5 co-receptor antagonist for treatment of HIV
07/25/2007 Label changes for BARACLUDE (entecavir) Tablets and Oral Solution
07/18/2007 Advisory committee meeting scheduled to discuss raltegravir
07/13/2007 Tentative approval of generic efavirenz
06/18/2007 FDA approval of Lexiva oral suspension and label changes for pediatric patients and patients with hepatic impairment
05/25/2007 Three new HIV assays approved
05/24/2007 Generic zidovudine capsules approved
04/23/2007 Tentative approval of generic stavudine
04/23/2007 Updated Kaletra Labeling
04/18/2007 Change of location notice for April 24, 2007 Antiviral Drugs Advisory Committee meeting
04/07/2007 Important notice about Combivir and Ziagen
04/06/2007 Tentative approval of generic abacavir sulfate tablets
03/27/2007 Tentative approval of efavirenz tablets
03/19/2007 Tentative approval of lamivudine tablets
03/16/2007 Two tentative approvals
stavudine/lamivudine tablets co-packaged with nevirapine tablets, and stavudine/lamivudine tablets
03/09/2007 Public Health Advisory: erythropoiesis-stimulating agents (ESAs)
03/09/2007 Approval of generic didanosine for oral solution
03/07/2007 Final Guidance: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products
03/06/2007 Tentative approval lamivudine/zidovudine + nevirapine
02/26/2007 Baraclude (entecavir) label revisions related to certain HIV-infected patients being treated for chronic hepatitis B
02/09/2007 Upcoming FDA advisory committee meeting: maraviroc
01/31/2007 Important changes to Fuzeon product labeling
01/23/2007 Tentative approval of new fixed dose combination: lamivudine/stavudine

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2006

12/29/2006 FDA approves Radiesse for treating facial lipoatrophy
12/20/2006 Egg Safety during the Holiday Season
12/12/2006 FDA Proposes Rules to Expand Availability of Investigational Drugs and Clarify Permissible Charges to Patients
12/01/2006 World AIDS Day
11/22/2006 Erythropoiesis Stimulating Agents (ESA) Safety Alert
11/20/2006 Tentative approval of new triple drug Fixed dose combination:
stavudine/lamivudine/nevirapine tablets
11/06/2006 Tentative approval of generic abacavir sulfate
10/30/2006 Pediatric Guidelines Updated
10/25/2006 Guidance: Fixed Dose Combinations, Co-Packaged Drug Products, and Previously Approved Antiretrovirals
10/23/2006 New 300 mg Reyataz capsule approved
10/11/2006 Revised Adult HIV Treatment Guidelines available
10/06/2006 Tentative approval of generic didanosine for oral solution
10/06/2006 Approval of HIV-1 RNA qualitative assay for diagnostic use
09/14/2006 Tentative approval, fixed dose combination: lamivudine/zidovudine
09/05/2006 Antiviral Drugs Advisory Committee to discuss design issues in the development of products for treatment of chronic Hepatitis C, including co-infection with HIV
08/30/2006 Tentative approval of generic stavudine capsules
08/24/2006 Tentative approval of fixed does lamivudine/zidovudine tablet
08/14/2006 Tentative approval of generic nevirapine formulation
08/02/2006 Health warning about raw oysters from Pacific Northwest
07/26/2006 Tentative approval of lamivudine/zidovudine copackaged with abacavir sulfate
07/26/2006 Important notification regarding the Vironostika HIV-1 test kit
07/12/2006 FDA approval of Atripla, 3-drug fixed dose combination antiretroviral
07/12/2006 Updated Perinatal Guidelines
07/10/2006 Tentative approval for didanosine chewable tablets
06/30/2006 Important safety information about Aptivus (tipranavir)
06/30/2006 Tentative approval for a fixed-dose, three-ingredient tablet to treat HIV/AIDS
06/28/2006 Tentative approval: generic Abacavir Sulfate Oral Solution
06/28/2006 Tentative approval: generic stavudine 15 & 20 mg capsules
06/23/2006 Accelerated approval of Prezista
06/23/2006 Tentative approval of generic lamivudine oral solution
06/08/2006 Final Guidance for Industry on Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency
05/26/2006 Free webcast of CCR5 co-receptor meeting
05/26/2006 Tentative approval of generic abacavir tablets
05/05/2006 Development of Preventive HIV Vaccines for Use in Pediatric Populations
05/04/2006 Updated Adult HIV Treatment Guidelines
03/31/2006 Generic zidovudine in capsule form
03/29/2006 Tentative approval of generic zidovudine, 100 mg capsules
03/10/2006 Traditional approval of Viread and Truvada
03/08/2006 Tentative approval of copackaged antiviral regimen - lamivudine/zidovudine fixed dose combination tablets and efavirenz tablets
03/02/2006 OTC HIV Rapid Tests: Issue Summary
03/01/2006 Notice of upcoming Blood Products Advisory Committee Meeting: Home-use HIV Test
02/13/2006 Workshop on Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing (NAT)
02/10/2006 Date set for meeting re: development issues for CCR5 co-receptor antagonists for the treatment of HIV infection
01/26/2006 Atazanavir labeling changes
01/18/2006 New Prescription Drug Information Format to Improve Patient Safety

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2005

12/27/2005 Tentative approval of nevirapine oral suspension
12/22/2005 Tentative approval for pediatric formulation of stavudine
12/21/2005 Reports of false positive oral rapid test results
12/07/2005 Tenth anniversary of the first protease inhibitor approval
12/01/2005 CCR5 antagonist meeting postponed
11/21/2005 CCR5 co-receptor antagonists meeting announcement
11/17/2005 Proposed Guidance for Condom Labeling
11/17/2005 Perinatal Guidelines Update
11/04/2005 Pediatric Treatment Guidelines Updated
10/28/2005 FDA approval of new formulation of Kaletra
10/13/2005 Notice of upcoming Blood Products Safety Advisory Committee meeting
(OTC HIV rapid test)
10/06/2005 Dosing recommendations for NORVIR (ritonavir) in pediatric patients one month to two years of age
09/28/2005 Emtriva: New formulation and labeling changes
09/23/2005 Important Recommendations for Non-HIV-Specialize d Providers Caring for Displaced HIV-Infected Residents from the Hurricane Disasters
09/20/2005 Approval of generic zidovudine formulations for US market
09/07/2005 Tentative approval of generic zidovudine
08/16/2005 PDE-5 Inhibitors and HIV Risk: Conference Notice
07/07/2005 Tentative approval of generic lamivudine/zidovudine combination
07/01/2005 Tentative approval or generic stavudine
06/23/2005 FDA approval of Aptivus (tipranavir)
05/31/2005 Approval of generic foscarnet sodium for treatment of CMV retinitis
05/26/2005 Fortovase distribution to be discontinued
05/25/2005 FDA Issues Draft Guidance for the Development of Antiviral Drug Products
05/13/2005 New 30-count Size Bottle Approved for Norvir (ritonavir) 100 mg Soft Gelatin Capsules
05/13/2005 New Labeling for Viread (tenofovir disoproxil fumarate)
04/29/2005 Approval of KALETRA 800/200mg Once-daily Administration for the Treatment of HIV-infection in Therapy-naïve Adult Patients
04/08/2005 Adult Treatment Guidelines Updated
04/04/2005 Notice of Upcoming Advisory Committee Meeting - Tipranavir
03/31/2005 Important Information About Sustiva (efavirenz) and Pregnancy
03/30/2005 Approval of Baraclude (entecavir) for Treatment of Chronic Hepatitis B Virus Infection
03/24/2005 Updated Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection
03/02/2005 Pegasys and Copegus Indications Expanded to Include Treatment of Hepatitis C and HIV Coinfection
02/08/2005 Drug Interaction Warning: Saquinavir/ritonavir and Rifampin
02/07/2005 FDA Warning - Unapproved Home-use Diagnostic Test Kits
01/26/2005 Tentative Approval of Copackaged Antiretroviral for PEPFAR Availability

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2004

12/30/2004 Approval of Multispot HIV-1 / HIV-2 Rapid Test
12/27/2004 Crixivan (indinavir) label revised ~ Not recommended for HIV-infected pregnant patients
12/20/2004 Atazanavir, with or without ritonavir should not be coadministered with proton pump inhibitors
12/17/2004 New 500 mg Tablet Formulation of Invirase (saquinavir) Approved
12/03/2004 Approval of Generic ddI
12/01/2004 Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection Update
11/26/2004 Draft Guidance: Role of HIV Drug Resistance Testing in Antiretroviral Drug Development
11/17/2004 Final Guidance: Use of Nucleic Acid Tests for Blood Screening for HIV-1 and HCV
11/12/2004 Dear Healthcare Provider letter regarding early virologic failures on Videx/Viread
10/29/2004 Availability of Revised HIV Treatment Guidelines
10/22/2004 Fuzeon (enfuvirtide, T-20) Accelerated to Traditional Approval / Label Revisions
10/22/2004 Kaletra (lopinavir and ritonavir) Labeling Revisions
09/14/2004 Exploring Scientific Opportunities for Facilitating Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies
09/08/2004 Meeting of FDA's Vaccines and Related Biological Products Advisory Committee
08/17/2004 Sustiva labeling revisions
08/03/2004 FDA approval of Sculptra for treating facial lipoatrophy
08/02/2004 Two new Fixed Dose Combinations Approved
07/27/2004 New HIV/AIDS Advisory Committee Records Web Page
07/07/2004 New Dosing Regimen for REYATAZ/ritonavir in Treatment-Experienced Patients
07/06/2004 VIREAD (tenofovir disoproxil fumerate) Label Update
05/21/2004 CLIA Waiver granted to OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
05/20/2004 New Rule and Draft Guidance Issued for Human Cell and Tissue Donor Screening
05/12/2004 Changes to Crixivan (indinavir sulfate) capsules product label and patient package insert
05/04/2004 Labeling changes for Voriconazole (VFEND) antifungal, when coadministered with efavirenz or ritonavir
04/07/2004 FDA Approval of Generic Ribavirin for Treatment of Chronic Hepatitis C
03/26/2004 3 issues related to Rapid Testing for HIV
03/22/2004 Revised Pediatric Dosing Recommendations for Viracept (nelfinavir)
03/19/2004 Important new information about atazanavir drug interaction
01/13/2004 Changes to Crixivan Labeling
01/02/2004 FDA Approval of New, 10 Minute Rapid HIV Test

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2003

12/29/2003 New Dosing Regimens for INVIRASE and FORTOVASE (saquinavir)
11/14/2003 Revised Adult HIV Treatment Guidelines
11/04/2003 Revised labeling for VIREAD (tenofovir disoproxi l fumarate) 300mg Tablets
10/21/2003 FDA approves LEXIVA (Fosamprenavir calcium)
10/16/2003 Medication Dispensing Errors ~ Kaletra (lopinavir/ritonavir) and Keppra (levetiracetam)
10/14/2003 Important Drug Warning: Once-Daily Triple NRTI Regimen containing Didanosine, Lamivudine, and Tenofovir
10/10/2003 Live Help is now available on AIDSinfo.nih.gov
10/09/2003 Recent Changes to Norvir (ritonavir) Product Labeling
08/15/2003 New Information in Viread Label
08/08/2003 Important New Pharmacokinetic Data for REYATAZ™ (atazanavir sulfate) in combination with Viread® (tenofovir disoproxil fumarate)
08/08/2003 New information about treatment of Latent Tuberculosis Infection in HIV infected and Uninfected Individuals
07/25/2003 Dear Health Care Provider Letter from GlaxoSmithKline (re: Lamivudine, Abacavir and Tenofovir)
07/02/2003 FDA Approval of Emtriva for treating HIV
06/23/2003 FDA Approves Atazanavir, a Once Daily Protease Inhibitor for HIV Infection
06/12/2003 Advisory Committee Meeting Notice - development of topical microbicides to reduce HIV transmission
04/30/2003 FDA approves new, alternate dosing formulation of Viracept
04/28/2003 A Catalog of FDA Approved Drug Products
04/04/2003 Antiviral Drugs Advisory Committee Meeting - Atazanavir / valacyclovir
04/01/2003 Integrating Nutrition Therapy into Medical Management of HIV
03/13/2003 FDA approves Fuzeon
03/12/2003 Counterfeit Procrit
03/11/2003 FDA Proposes Labeling and Manufacturing Standards For All Dietary Supplements
02/24/2003 Pediatric Advisory Committee Meeting: HIV drug development in neonates
01/16/2003 FDA proposes warning labeling for OTC vaginal contraceptives containing nonoxynol 9

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2002

12/31/2003 Approval of ZERIT® XR, a new formulation that allows once-a-day dosing
12/02/2002 Launch of new AIDSInfo Website
11/07/2002 FDA approves new rapid HIV test kit
11/01/2002 New guidance on clinical trial design in developing treatment for HIV infection
10/11/2002 Anitviral Advisory Committee to consider application for peginterferon alfa-2a + ribavirin for treatment of Hepatitis C
09/25/2002 New Safety Information -Viread co-administration with Videx
09/25/2002 New Safety Information for Videx (Didanosine, ddI) used with Ribavirin
09/23/2002 FDA Approves Viral Load Test ~ VERSANT® HIV-1 RNA 3.0 Assay (bDNA)
09/23/2002 FDA Approves new treatment for chronic Hepatitis B - see note on HIV resistance
09/06/2002 Availability of nandrolone decanoate
08/12/2002 Important Changes in Agenerase Product Labeling
07/03/2002 Prescription drug information for patients
07/02/2002 New Dosing approved for Epivir (lamivudine)
06/12/2002 Important information about counterfeit PROCRIT (epoetin alfa) - Two lot numbers
05/12/2002 Important information about counterfeit EPOGEN
05/20/2002 Notification of Counterfeit Serostim
05/15/2002 Product Tampering that Incorrectly Labels Ziagen as Combivir
03/01/2002 Changes in ZERIT product labeling reflect potential safety concerns
02/15/2002 Cytovene-IV Shortage - additional information

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