ERVEBO is an Ebola Zaire vaccine
Tradename: ERVEBO Proper Name: Ebola Zaire Vaccine, Live Indication: To extend the indication for use to include individuals 12 months of age and older. ERVEBO is a vaccine indicated for…
DENGVAXIA vaccine for prevention of dengue disease caused by dengue virus
Tradename: DENGVAXIA Proper Name: Dengue Tetravalent Vaccine, Live Indication: To include safety and efficacy data that support the use of DENGVAXIA in individuals 6 through 16 years of age with…
Elecsys HIV Duo to screen blood donors
Tradename: Elecsys HIV Duo Proper Name: Elecsys HIV Duo Indication: Intended to screen individual human donors, including volunteer donors of whole blood, blood components and source plasma. The assay is…
MenQuadfi for active prevention of invasive meningococcal disease
Tradename: MenQuadfi Proper Name: Meningococcal (Groups A, C, Y, W) Conjugate Vaccine Indication: To include safety and effectiveness data from clinical studies MET59 and MEQ66 in support of booster vaccination…
VAXNEUVANCE for prevention of invasive disease by Streptococcus pneumoniae
Tradename: VAXNEUVANCE Proper Name: Pneumococcal 15-valent Conjugate Vaccine Indication: To include results from study V114-022 in the “Use in Specific Populations” section of the package insert, for pediatric and adult…
SHINGRIX for prevention of herpes zoster (shingles)
Tradename: SHINGRIX Proper Name: Zoster Vaccine Recombinant, Adjuvanted Indication: To include data on safety and the immune responses to SHINGRIX when administered concomitantly with Pneumococcal Vaccine Polyvalent (Pneumovax 23), Pneumococcal…
GARDASIL 9
Tradename: GARDASIL 9 Proper Name: Human Papillomavirus 9-valent Vaccine, Recombinant Indication: To include clinical data from the long-term follow-up study V503-002-20 in support of modifications to the package insert. …
WOWST to prevent recurrence of Clostridioides difficile infection
Tradename: VOWST Proper Name: fecal microbiota spores, live-brpk Indication: To prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for…
Sunlenca to treat challenging HIV infections
Drug Name: Sunlenca Active Ingredient: lenacapavir Indications: To treat adults with HIV whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations…
Voquezna to treat Helicobacter pylori infection
Drug Name: Voquezna Active Ingredient: vonoprazan, amoxicillin, and clarithromycin Indications: To treat Helicobacter pylori infection Approval Date: 5/3/2022 Company: Phathom Pharmaceuticals, Inc. More: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215152s000,215153s000lbl.pdf