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Submission status for AMGEN INC's drug REPATHA (SUPPL-47) with active ingredient EVOLOCUMAB has changed to 'Approval' on 10/09/2026. Application Category: BLA, Application Number: 125522, Application Classification:
Submission status for LANNETT CO INC's drug DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (SUPPL-5) with active ingredient AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE has changed to 'Approval' on 10/05/2026. Application Category: ANDA, Application Number: 214403, Application Classification: Labeling
Submission status for LANNETT CO INC's drug DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (SUPPL-6) with active ingredient AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE has changed to 'Approval' on 10/05/2026. Application Category: ANDA, Application Number: 214403, Application Classification: Labeling
Submission status for ABBVIE INC's drug JUVMO (ORIG-1) with active ingredient TAVAPADON has changed to 'Approval' on 09/25/2026. Application Category: NDA, Application Number: 220415, Application Classification: Type 1 - New Molecular Entity
Submission status for PFIZER INC's drug RUXIENCE (SUPPL-20) with active ingredient RITUXIMAB-PVVR has changed to 'Approval' on 09/28/2026. Application Category: BLA, Application Number: 761103, Application Classification:
Submission status for LANNETT CO INC's drug LISDEXAMFETAMINE DIMESYLATE (SUPPL-8) with active ingredient LISDEXAMFETAMINE DIMESYLATE has changed to 'Approval' on 09/24/2026. Application Category: ANDA, Application Number: 215802, Application Classification: Labeling
Submission status for LANNETT CO INC's drug LISDEXAMFETAMINE DIMESYLATE (SUPPL-6) with active ingredient LISDEXAMFETAMINE DIMESYLATE has changed to 'Approval' on 09/24/2026. Application Category: ANDA, Application Number: 215802, Application Classification: Labeling
Submission status for AMGEN INC's drug RIABNI (SUPPL-5) with active ingredient RITUXIMAB-ARRX has changed to 'Approval' on 09/29/2026. Application Category: BLA, Application Number: 761140, Application Classification:
Submission status for PFIZER INC's drug RUXIENCE (SUPPL-20) with active ingredient RITUXIMAB-PVVR has changed to 'Approval' on 09/29/2026. Application Category: BLA, Application Number: 761103, Application Classification:
Submission status for AGIOS PHARMS INC's drug PYRUKYND (SUPPL-7) with active ingredient MITAPIVAT SULFATE has changed to 'Approval' on 09/28/2026. Application Category: NDA, Application Number: 216196, Application Classification: Manufacturing (CMC)
Submission status for AGIOS PHARMS INC's drug AQVESME (SUPPL-7) with active ingredient MITAPIVAT SULFATE has changed to 'Approval' on 09/28/2026. Application Category: NDA, Application Number: 216196, Application Classification: Manufacturing (CMC)
Submission status for AMGEN INC's drug IMDELLTRA (SUPPL-2) with active ingredient TARLATAMAB-DLLE has changed to 'Approval' on 09/11/2026. Application Category: BLA, Application Number: 761344, Application Classification:
Submission status for IONIS PHARMS INC's drug ZANVASTRO (ORIG-1) with active ingredient ZILGANERSEN has changed to 'Approval' on 09/03/2026. Application Category: NDA, Application Number: 220210, Application Classification: Type 1 - New Molecular Entity
Submission status for GILEAD SCIENCES INC's drug SUNLENCA (SUPPL-17) with active ingredient LENACAPAVIR SODIUM has changed to 'Approval' on 08/27/2026. Application Category: NDA, Application Number: 215974, Application Classification: Efficacy
Submission status for GILEAD SCIENCES INC's drug SUNLENCA (SUPPL-24) with active ingredient LENACAPAVIR SODIUM has changed to 'Approval' on 08/27/2026. Application Category: NDA, Application Number: 215973, Application Classification: Efficacy
Submission status for REVOLUTION MEDICINES INC's drug RASONQUE (ORIG-1) with active ingredient DARAXONRASIB has changed to 'Approval' on 08/26/2026. Application Category: NDA, Application Number: 220910, Application Classification: Type 1 - New Molecular Entity
Submission status for DR. REDDY'S LABORATORIES LIMITED's drug BEMPEDOIC ACID (ORIG-1) with active ingredient BEMPEDOIC ACID has changed to 'Tentative Approval' on 08/06/2026. Application Category: ANDA, Application Number: 219312, Application Classification:
Submission status for REGENERON PHARMACEUTICALS, INC's drug PASATRU (ORIG-1) with active ingredient GARETOSMAB has changed to 'Approval' on 08/19/2026. Application Category: BLA, Application Number: 761508, Application Classification:
Submission status for LANNETT CO INC's drug METAXALONE (SUPPL-17) with active ingredient METAXALONE has changed to 'Approval' on 08/19/2026. Application Category: ANDA, Application Number: 204770, Application Classification: Labeling
Submission status for LANNETT CO INC's drug BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (SUPPL-31) with active ingredient BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE has changed to 'Approval' on 08/14/2026. Application Category: ANDA, Application Number: 205022, Application Classification: REMS
