Suspensions of killed or attenuated microorganisms (bacteria, viruses, fungi, protozoa), antigenic proteins, synthetic constructs, or other bio-molecular derivatives, administered for the prevention, amelioration, or treatment of infectious and other diseases.
DrugDrug NameDrug Indication
DB10318Varicella Zoster Vaccine (Live/Attenuated)Zostavax vaccine is indicated for the prevention of herpes zoster (shingles) in immunocompetent adults aged 50 years and older. Varivax vaccine is indicated for active immunization for the prevention of varicella in individuals 12 months of age and older.
DB10805Yellow Fever VaccineYellow Fever Vaccine is indicated for active immunization for the prevention of yellow fever in persons 9 months of age and older in the following categories: 1. Persons Living in or Traveling to Endemic Areas: While the actual risk for contracting yellow fever during travel is probably low, variability of itineraries, behaviors and seasonal incidence of disease make it difficult to predict the actual risk for a given individual living in or traveling to a known endemic or epidemic area. Greater risk is associated with living in or traveling to areas of South America and Africa where yellow fever infection is officially reported at the time of travel and with traveling outside the urban areas of countries that do not officially report the disease but that lie in a yellow fever endemic zone. 2. Persons Travelling Internationally Through Countries with Yellow Fever: Some countries require an individual to have a valid International Certificate of Vaccination or Prophylaxis (ICVP) if the individual has been in countries either known or thought to harbor yellow fever virus. The certificate becomes valid 10 days after vaccination with Yellow Fever Vaccine. 3. Laboratory Personnel: Laboratory personnel who handle virulent yellow fever virus or concentrated preparations of the yellow fever vaccine virus strains may be at risk of exposure by direct or indirect contact or by aerosols.
DB10583Clostridium tetani toxoid antigen (formaldehyde inactivated)Not Available
DB10584Corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated)Not Available
DB10276Rotavirus VaccineRotarix is indicated for prevention of rotavirus gastroenteritis caused by G1, G3, G4, and G9 types in infants aged 6-24 weeks [FDA Label]. Rotateq is indicated for the prevention of rotavirus gastroenteritis caused by G1, G2, G3, G4, and G9 types in infants aged 6-32 weeks [L1116].
DB04914G17DTIntended for the treatment of various forms of cancer.
DB05325INGN 225Investigated for use/treatment in breast cancer, head and neck cancer, and lung cancer.
DB05374RindopepimutInvestigated for use/treatment in brain cancer.
DB05440SRP 299Investigated for use/treatment in asthma, atopic dermatitis, and pediatric atopic dermatitis indications.
DB05942GI-5005Investigated for use/treatment in hepatitis (viral, C).
DB06584TG4010Investigated for use/treatment in breast cancer, renal cell carcinoma, prostate cancer, and lung cancer.
DB10283Rabies virus inactivated antigen, ANot Available
DB12568TecemotideNot Available
DB12768BCG vaccineNot Available
DB14022Typhoid vaccineNot Available
DB10317Rubella virus vaccineNot Available
DB09057Anthrax immune globulin humanAnthrax immune globulin is indicated for the treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs.
DB10343Bacillus calmette-guerin substrain tice live antigenNot Available
DB10769Japanese encephalitis virus strain sa 14-14-2 antigen (formaldehyde inactivated)Not Available
DB10803Salmonella typhi ty2 vi polysaccharide antigenNot Available
DB10804Bacillus calmette-guerin substrain connaught live antigenIndicated for intravesical use in the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder and for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR).
DB10989Hepatitis A VaccineHepatitis A vaccine is indicated for active immunization against disease caused by hepatitis A virus (HAV). It is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV. HAVRIX® will not prevent hepatitis infection caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus or other pathogens known to infect the liver. In areas of low to intermediate prevalence of hepatitis A, immunization with HAVRIX® is particularly recommended in subjects who are, or will be, at increased risk of infection such as: * Travelers: Persons traveling to areas where the prevalence of hepatitis A is high. These areas include Africa, Asia, the Mediterranean basin, the Middle East, Central and South America. * Armed Forces: Armed Forces personnel who travel to higher endemicity areas or to areas where hygiene is poor have an increased risk of HAV infection. Active immunization is indicated for these individuals. * Persons for whom Hepatitis A is an Occupational Hazard: These include employees in day-care centres, nursing, medical and paramedical personnel in hospitals and institutions, especially gastroenterology and pediatric units, sewage workers, and food handlers, among others. * Persons for whom there is an Increased Risk of Transmission of Hepatitis A: e.g. homosexuals, persons with multiple sexual partners, abusers of injectable drugs, hemophiliac patients. * Contacts of Infected Persons: Since virus shedding of infected persons may occur for a prolonged period, active immunization of close contacts is recommended. * Specific Population Groups known to have Higher Incidence of Hepatitis A: e.g. North American Indians, Inuits, recognized community-wide HAV epidemics. * Subjects with chronic liver disease or who are at risk of developing chronic liver disease e.g. Hepatitis B (HB) and Hepatitis C (HC) chronic carriers and alcohol abusers.
DB11050Typhoid Vaccine Live Ty21aNot Available
DB11603Human rabies virus immune globulinFor use in prophylaxis against rabies virus in patients who have been exposed to the virus and are immunocompromised or have not previously recieved the rabies vaccine [FDA Label].
DB11627Hepatitis B Vaccine (Recombinant)Active immunization against hepatitis B virus infection. The vaccine will not protect against infection caused by hepatitis A and non-A non-B hepatitis viruses. As hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection or carrier state, it can be expected that hepatitis D will also be prevented by vaccination with hepatitis B virus vaccine. The vaccine can be administered at any age from birth onwards. It may be used to start a primary course of vaccination or as a booster dose. It may also be used to complete a primary course of vaccination started with plasma-derived or yeast-derived vaccines or as a booster dose in subjects who have previously received a primary course of vaccination with plasma-derived or yeast-derived vaccines. In areas of low prevalence of hepatitis B, vaccination is strongly recommended in subjects who are at increased risk of infection. These include the following groups: * Health professionals: physicians and surgeons; oral surgeons and dentists; nurses, dental nurses, dental hygienists, podiatrists; IV teams and operating room personnel; paramedical personnel in close contact with patients; staff in hemodialysis, nephrology, hepatology, hematology and oncology units; laboratory personnel handling blood and other clinical specimens; blood bank and plasma fractionation workers; pathologists and morgue attendants; cleaning staff who handle waste in hospitals; emergency and first aid workers; ambulance staff; dental, medical and nursing students. * Patients: patients receiving frequent blood transfusion or clotting factor concentrates, such as those in oncology units and those with thalassemia, sickle-cell anemia, cirrhosis, hemophilia, etc.; patients on hemodialysis; patients with type 2 diabetes. * Personnel and residents of institutions: persons with frequent and/or close contacts with high-risk groups; prisoners and prison staff; residents and staff of institutions for the developmentally challenged (those who are in contact with aggressive biting residents being at highest risk). * Persons at increased risk due to their sexual practices: males having sexual contact with other males; others with multiple sexual partners or with a recent history of sexually transmitted disease. * Persons who use injectable drugs illicitly. * Travellers to areas of high endemicity and their close contacts. * Household contacts of any of the above groups and of patients with acute or chronic hepatitis B infection. * Infants born of HBsAg-positive mothers. * Chronic Liver Disease (CLD): subjects with chronic liver disease; subjects at risk of developing CLD (e.g. Hepatitis C virus carriers, persons who abuse alcohol). * Others: police; fire fighters; armed forces personnel; morticians and embalmers; those who through their work or personal lifestyle may be exposed to the hepatitis B virus. * In areas of both low and high prevalence, vaccination should be offered to all young children and neonates at risk, as well as to adult high risk groups.
DB11003Anthrax vaccineNot Available
DB12386Bacillus calmette-guerin substrain danish 1331 live antigenNot Available
DB14443Vibrio cholerae CVD 103-HgR strain live antigenNot Available
DB14409Human adenovirus e serotype 4 strain cl-68578 antigenNot Available
DB14685Adenovirus type 7 vaccine liveNot Available
DB14711Vaccinia virus strain new york city board of health live antigenNot Available
DB10062Rabies virus inactivated antigen, BNot Available
DB05144PEV3AInvestigated for use/treatment in malaria.
DB06400VitespenInvestigated for use/treatment in kidney cancer, melanoma, renal cell carcinoma, lymphoma (unspecified), colorectal cancer, and brain cancer.
DB10076Haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigenNot Available
DB10342Haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigenNot Available
DB10990Haemophilus influenzae type b strain 20752 capsular polysaccharide tetanus toxoid conjugate antigenIndicated for active immunization in pediatric patients 15 months through 4 years of age as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b.
DB11038Influenza a virus a/brisbane/59/2007(h1n1) hemagglutinin antigen (propiolactone inactivated)Not Available
DB11041Influenza a virus a/california/7/2009 x-181 (h1n1) hemagglutinin antigen (propiolactone inactivated)Not Available
DB14384Influenza a virus a/victoria/210/2009 x-187 (h3n2) hemagglutinin antigen (formaldehyde inactivated)Not Available
DB14445Influenza a virus a/victoria/210/2009 x-187 (h3n2) antigen (formaldehyde inactivated)Not Available
DB10600Influenza a virus a/california/7/2009 x-181 (h1n1) antigen (propiolactone inactivated)Not Available
DB14394Influenza a virus a/california/7/2009 (h1n1) live (attenuated) antigenNot Available
DB14449Influenza a virus a/perth/16/2009 (h3n2) live (attenuated) antigenNot Available
DB10794Influenza b virus b/brisbane/60/2008 antigen (formaldehyde inactivated)Not Available
DB11040Influenza b virus b/brisbane/60/2008 hemagglutinin antigen (propiolactone inactivated)Not Available
DB11044Influenza b virus b/brisbane/60/2008 antigen (propiolactone inactivated)Not Available
DB14385Influenza b virus b/brisbane/60/2008 hemagglutinin antigen (formaldehyde inactivated)Not Available
DB15274Pertussis vaccineNot Available
DB15461Yersinia pestis 195/p antigen (formaldehyde inactivated)Not Available