approval database

FDA Drug Approvals

Every published FDA drug approval submission Argus has observed, filterable by year and review pathway.

• VERA THERAPEUTICS INC. — BLA approval: TRUTAKNA (unspecified)

  VERA THERAPEUTICS INC.·Priority review·July 7, 2026

• QUAGEN — ANDA approval: MORPHINE SULFATE (unspecified)

  QUAGEN·Standard review·July 7, 2026

• ANNORA PHARMA — ANDA approval: DESOGESTREL AND ETHINYL ESTRADIOL (unspecified)

  ANNORA PHARMA·Standard review·July 7, 2026

• STIRA — ANDA approval: DIMETHYL SULFOXIDE (unspecified)

  STIRA·Standard review·July 7, 2026

• SOMERSET THERAPS LLC — ANDA approval: VARENICLINE TARTRATE (unspecified)

  SOMERSET THERAPS LLC·Standard review·July 6, 2026

• PADAGIS ISRAEL — ANDA approval: NITROGLYCERIN (unspecified)

  PADAGIS ISRAEL·Standard review·July 6, 2026

• BAXTER HLTHCARE CORP — ANDA approval: LEVOCARNITINE (unspecified)

  BAXTER HLTHCARE CORP·Standard review·July 2, 2026

• SANDOZ — ANDA approval: LIRAGLUTIDE (unspecified)

  SANDOZ·Standard review·July 1, 2026

• SABA ILAC SANAYIVE — ANDA approval: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (unspecified)

  SABA ILAC SANAYIVE·Standard review·July 1, 2026

• NOVARTIS — NDA approval: KISQALI (unspecified)

  NOVARTIS·Priority review·July 1, 2026

• NOVARTIS — NDA approval: KISQALI FEMARA CO-PACK (COPACKAGED) (unspecified)

  NOVARTIS·Priority review·July 1, 2026

• MANKIND PHARMA — ANDA approval: RIVAROXABAN (unspecified)

  MANKIND PHARMA·Standard review·July 1, 2026

• MACLEODS PHARMS LTD — ANDA approval: CHLORTHALIDONE (unspecified)

  MACLEODS PHARMS LTD·Standard review·July 1, 2026

• SCIEGEN PHARMS — ANDA approval: BRIVARACETAM (unspecified)

  SCIEGEN PHARMS·Standard review·July 1, 2026

• UNIQUE — ANDA approval: ADAPALENE (unspecified)

  UNIQUE·Standard review·June 30, 2026

• I3 PHARMS — ANDA approval: EVEROLIMUS (unspecified)

  I3 PHARMS·Standard review·June 30, 2026

• ZYDUS PHARMS — ANDA approval: SELENIOUS ACID (unspecified)

  ZYDUS PHARMS·Standard review·June 30, 2026

• MICRO LABS — ANDA approval: RIVAROXABAN (unspecified)

  MICRO LABS·Standard review·June 30, 2026

• NOVITIUM PHARMA — ANDA approval: RIFAMPIN (unspecified)

  NOVITIUM PHARMA·Standard review·June 29, 2026

• MICRO LABS — ANDA approval: PRUCALOPRIDE SUCCINATE (unspecified)

  MICRO LABS·Standard review·June 29, 2026

• APOTEX — ANDA approval: POSACONAZOLE (unspecified)

  APOTEX·Standard review·June 29, 2026

• GE HLTHCARE — ANDA approval: PIXXOSCAN (unspecified)

  GE HLTHCARE·Standard review·June 29, 2026

• NOVITIUM PHARMA — ANDA approval: TRAMADOL HYDROCHLORIDE (unspecified)

  NOVITIUM PHARMA·Standard review·June 26, 2026

• VIRIDIAN THERAPEUTICS INC — BLA approval: LUMVOA (unspecified)

  VIRIDIAN THERAPEUTICS INC·Priority review·June 26, 2026

• TEVA PHARMS INC — ANDA approval: NILOTINIB HYDROCHLORIDE (unspecified)

  TEVA PHARMS INC·Standard review·June 26, 2026