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FDA Approvals

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Live FDA approvals and announcements.

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  • Lannett Co Inc logo
    FDA··Health Care·
    $LCI
    FDA Approval for OXYCODONE AND ACETAMINOPHEN issued to LANNETT CO INC

    Submission status for LANNETT CO INC's drug OXYCODONE AND ACETAMINOPHEN (SUPPL-18) with active ingredient ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE has changed to 'Approval' on 06/18/2026. Application Category: ANDA, Application Number: 207333, Application Classification: REMS

  • Lannett Co Inc logo
    FDA··Health Care·
    $LCI
    FDA Approval for OXYCODONE HYDROCHLORIDE issued to LANNETT CO INC

    Submission status for LANNETT CO INC's drug OXYCODONE HYDROCHLORIDE (SUPPL-16) with active ingredient OXYCODONE HYDROCHLORIDE has changed to 'Approval' on 06/18/2026. Application Category: ANDA, Application Number: 203823, Application Classification: REMS

  • Lannett Co Inc logo
    FDA··Health Care·
    $LCI
    FDA Approval for CODEINE SULFATE issued to LANNETT CO INC

    Submission status for LANNETT CO INC's drug CODEINE SULFATE (SUPPL-21) with active ingredient CODEINE SULFATE has changed to 'Approval' on 06/18/2026. Application Category: ANDA, Application Number: 203046, Application Classification: REMS

  • Amphastar Pharmaceuticals Inc. logo
    FDA··Health Care·
    $AMPH
    FDA Approval for REXTOVY issued to AMPHASTAR PHARMS INC

    Submission status for AMPHASTAR PHARMS INC's drug REXTOVY (SUPPL-2) with active ingredient NALOXONE HYDROCHLORIDE has changed to 'Approval' on 06/16/2026. Application Category: NDA, Application Number: 208969, Application Classification: Efficacy

  • AbbVie Inc. logo
    FDA··Health Care·
    $ABBV
    FDA Approval for SKYRIZI issued to ABBVIE INC

    Submission status for ABBVIE INC's drug SKYRIZI (SUPPL-44) with active ingredient RISANKIZUMAB-RZAA has changed to 'Approval' on 06/12/2026. Application Category: BLA, Application Number: 761105, Application Classification:

  • AbbVie Inc. logo
    FDA··Health Care·
    $ABBV
    FDA Approval for SKYRIZI issued to ABBVIE INC

    Submission status for ABBVIE INC's drug SKYRIZI (SUPPL-15) with active ingredient RISANKIZUMAB-RZAA has changed to 'Approval' on 06/12/2026. Application Category: BLA, Application Number: 761262, Application Classification:

  • Provention Bio Inc. logo
    FDA··Health Care·
    $PRVB
    FDA Approval for TZIELD issued to PROVENTION BIO INC

    Submission status for PROVENTION BIO INC's drug TZIELD (SUPPL-10) with active ingredient TEPLIZUMAB-MZWV has changed to 'Approval' on 06/12/2026. Application Category: BLA, Application Number: 761183, Application Classification:

  • Provention Bio Inc. logo
    FDA··Health Care·
    $PRVB
    FDA Approval for TZIELD issued to PROVENTION BIO INC

    Submission status for PROVENTION BIO INC's drug TZIELD (SUPPL-14) with active ingredient TEPLIZUMAB-MZWV has changed to 'Approval' on 06/12/2026. Application Category: BLA, Application Number: 761183, Application Classification:

  • Pfizer Inc. logo
    FDA··Health Care·
    $PFE
    FDA Approval for HYMPAVZI issued to PFIZER INC

    Submission status for PFIZER INC's drug HYMPAVZI (SUPPL-3) with active ingredient MARSTACIMAB-HNCQ has changed to 'Approval' on 06/05/2026. Application Category: BLA, Application Number: 761369, Application Classification:

  • Sanofi logo
    FDA··Health Care·
    $SNY
    FDA Approval for CHILDREN'S ALLEGRA HIVES issued to CHATTEM SANOFI

    Submission status for CHATTEM SANOFI's drug CHILDREN'S ALLEGRA HIVES (SUPPL-19) with active ingredient FEXOFENADINE HYDROCHLORIDE has changed to 'Approval' on 06/04/2026. Application Category: NDA, Application Number: 021909, Application Classification: Labeling

  • Delcath Systems Inc. logo
    FDA··Health Care·
    $DCTH
    FDA Approval for HEPZATO issued to DELCATH SYSTEMS INC

    Submission status for DELCATH SYSTEMS INC's drug HEPZATO (SUPPL-16) with active ingredient MELPHALAN HYDROCHLORIDE has changed to 'Approval' on 05/29/2026. Application Category: NDA, Application Number: 201848, Application Classification: REMS

  • AbbVie Inc. logo
    FDA··Health Care·
    $ABBV
    FDA Approval for DECNUPAZ issued to ABBVIE INC

    Submission status for ABBVIE INC's drug DECNUPAZ (ORIG-1) with active ingredient PIVEKIMAB SUNIRINE-PVZY has changed to 'Approval' on 05/27/2026. Application Category: BLA, Application Number: 761460, Application Classification:

  • Gilead Sciences Inc. logo
    FDA··Health Care·
    $GILD
    FDA Approval for HEPCLUDEX issued to GILEAD SCIENCES INC

    Submission status for GILEAD SCIENCES INC's drug HEPCLUDEX (ORIG-1) with active ingredient BULEVIRTIDE-GMOD) has changed to 'Approval' on 05/22/2026. Application Category: BLA, Application Number: 761468, Application Classification:

  • Gilead Sciences Inc. logo
    FDA··Health Care·
    $GILD
    FDA Approval for BIKTARVY issued to GILEAD SCIENCES INC

    Submission status for GILEAD SCIENCES INC's drug BIKTARVY (SUPPL-26) with active ingredient BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE has changed to 'Approval' on 05/21/2026. Application Category: NDA, Application Number: 210251, Application Classification: Manufacturing (CMC)

  • Gilead Sciences Inc. logo
    FDA··Health Care·
    $GILD
    FDA Approval for BIKTARVY issued to GILEAD SCIENCES INC

    Submission status for GILEAD SCIENCES INC's drug BIKTARVY (SUPPL-26) with active ingredient BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE has changed to 'Approval' on 05/21/2026. Application Category: NDA, Application Number: 210251, Application Classification: Labeling

  • Sanofi logo
    FDA··Health Care·
    $SNY
    FDA Approval for XYZAL ALLERGY 24HR issued to CHATTEM SANOFI

    Submission status for CHATTEM SANOFI's drug XYZAL ALLERGY 24HR (SUPPL-10) with active ingredient LEVOCETIRIZINE DIHYDROCHLORIDE has changed to 'Approval' on 05/20/2026. Application Category: NDA, Application Number: 209089, Application Classification: Labeling