Live FDA approvals and announcements. https://www.quantisnow.com/news/fda en-us Wed, 30 Sep 2026 15:32:12 GMT 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 https://www.quantisnow.com/insight/fda-approval-for-juvmo-issued-to-abbvie-inc-6730048 https://www.quantisnow.com/insight/fda-approval-for-juvmo-issued-to-abbvie-inc-6730048 Wed, 30 Sep 2026 12:20:19 GMT 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: https://www.quantisnow.com/insight/fda-approval-for-ruxience-issued-to-pfizer-inc-6729735 https://www.quantisnow.com/insight/fda-approval-for-ruxience-issued-to-pfizer-inc-6729735 Wed, 30 Sep 2026 08:46:04 GMT 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 https://www.quantisnow.com/insight/fda-approval-for-lisdexamfetamine-dimesylate-issued-to-lannett-co-inc-6729734 https://www.quantisnow.com/insight/fda-approval-for-lisdexamfetamine-dimesylate-issued-to-lannett-co-inc-6729734 Wed, 30 Sep 2026 08:45:36 GMT 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 https://www.quantisnow.com/insight/fda-approval-for-lisdexamfetamine-dimesylate-issued-to-lannett-co-inc-6729733 https://www.quantisnow.com/insight/fda-approval-for-lisdexamfetamine-dimesylate-issued-to-lannett-co-inc-6729733 Wed, 30 Sep 2026 08:45:36 GMT 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: https://www.quantisnow.com/insight/fda-approval-for-riabni-issued-to-amgen-inc-6729618 https://www.quantisnow.com/insight/fda-approval-for-riabni-issued-to-amgen-inc-6729618 Tue, 29 Sep 2026 22:17:23 GMT 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: https://www.quantisnow.com/insight/fda-approval-for-ruxience-issued-to-pfizer-inc-6729617 https://www.quantisnow.com/insight/fda-approval-for-ruxience-issued-to-pfizer-inc-6729617 Tue, 29 Sep 2026 22:17:23 GMT 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) https://www.quantisnow.com/insight/fda-approval-for-pyrukynd-issued-to-agios-pharms-inc-6727202 https://www.quantisnow.com/insight/fda-approval-for-pyrukynd-issued-to-agios-pharms-inc-6727202 Mon, 28 Sep 2026 12:08:33 GMT 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) https://www.quantisnow.com/insight/fda-approval-for-aqvesme-issued-to-agios-pharms-inc-6727201 https://www.quantisnow.com/insight/fda-approval-for-aqvesme-issued-to-agios-pharms-inc-6727201 Mon, 28 Sep 2026 12:08:33 GMT 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: https://www.quantisnow.com/insight/fda-approval-for-imdelltra-issued-to-amgen-inc-6715200 https://www.quantisnow.com/insight/fda-approval-for-imdelltra-issued-to-amgen-inc-6715200 Tue, 15 Sep 2026 08:45:02 GMT 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 https://www.quantisnow.com/insight/fda-approval-for-zanvastro-issued-to-ionis-pharms-inc-6706519 https://www.quantisnow.com/insight/fda-approval-for-zanvastro-issued-to-ionis-pharms-inc-6706519 Fri, 04 Sep 2026 16:42:14 GMT 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 https://www.quantisnow.com/insight/fda-approval-for-sunlenca-issued-to-gilead-sciences-inc-6698211 https://www.quantisnow.com/insight/fda-approval-for-sunlenca-issued-to-gilead-sciences-inc-6698211 Fri, 28 Aug 2026 18:32:14 GMT 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 https://www.quantisnow.com/insight/fda-approval-for-sunlenca-issued-to-gilead-sciences-inc-6698173 https://www.quantisnow.com/insight/fda-approval-for-sunlenca-issued-to-gilead-sciences-inc-6698173 Fri, 28 Aug 2026 17:04:23 GMT 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 https://www.quantisnow.com/insight/fda-approval-for-rasonque-issued-to-revolution-medicines-inc-6698008 https://www.quantisnow.com/insight/fda-approval-for-rasonque-issued-to-revolution-medicines-inc-6698008 Fri, 28 Aug 2026 12:47:43 GMT 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: https://www.quantisnow.com/insight/fda-tentative-approval-for-bempedoic-acid-issued-to-dr-reddys-6695239 https://www.quantisnow.com/insight/fda-tentative-approval-for-bempedoic-acid-issued-to-dr-reddys-6695239 Wed, 26 Aug 2026 13:55:02 GMT 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: https://www.quantisnow.com/insight/fda-approval-for-pasatru-issued-to-regeneron-pharmaceuticals-inc-6693928 https://www.quantisnow.com/insight/fda-approval-for-pasatru-issued-to-regeneron-pharmaceuticals-inc-6693928 Tue, 25 Aug 2026 15:03:09 GMT 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 https://www.quantisnow.com/insight/fda-approval-for-metaxalone-issued-to-lannett-co-inc-6690645 https://www.quantisnow.com/insight/fda-approval-for-metaxalone-issued-to-lannett-co-inc-6690645 Fri, 21 Aug 2026 08:56:42 GMT 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 https://www.quantisnow.com/insight/fda-approval-for-buprenorphine-hydrochloride-and-naloxone-hydrochloride-issued-to-6684007 https://www.quantisnow.com/insight/fda-approval-for-buprenorphine-hydrochloride-and-naloxone-hydrochloride-issued-to-6684007 Mon, 17 Aug 2026 08:51:42 GMT Submission status for DELCATH SYSTEMS INC's drug HEPZATO (SUPPL-18) with active ingredient MELPHALAN HYDROCHLORIDE has changed to 'Approval' on 08/12/2026. Application Category: NDA, Application Number: 201848, Application Classification: REMS https://www.quantisnow.com/insight/fda-approval-for-hepzato-issued-to-delcath-systems-inc-6678937 https://www.quantisnow.com/insight/fda-approval-for-hepzato-issued-to-delcath-systems-inc-6678937 Thu, 13 Aug 2026 08:50:45 GMT Submission status for LEXICON PHARMS INC's drug INPEFA (SUPPL-3) with active ingredient SOTAGLIFLOZIN has changed to 'Approval' on 08/06/2026. Application Category: NDA, Application Number: 216203, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-inpefa-issued-to-lexicon-pharms-inc-6672714 https://www.quantisnow.com/insight/fda-approval-for-inpefa-issued-to-lexicon-pharms-inc-6672714 Mon, 10 Aug 2026 11:40:05 GMT Submission status for GILEAD SCIENCES INC's drug VEKLURY (SUPPL-33) with active ingredient REMDESIVIR has changed to 'Approval' on 07/29/2026. Application Category: NDA, Application Number: 214787, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-veklury-issued-to-gilead-sciences-inc-6654544 https://www.quantisnow.com/insight/fda-approval-for-veklury-issued-to-gilead-sciences-inc-6654544 Thu, 30 Jul 2026 08:49:17 GMT Submission status for VANDA PHARMS INC's drug HETLIOZ (SUPPL-13) with active ingredient TASIMELTEON has changed to 'Approval' on 07/27/2026. Application Category: NDA, Application Number: 205677, Application Classification: Manufacturing (CMC) https://www.quantisnow.com/insight/fda-approval-for-hetlioz-issued-to-vanda-pharms-inc-6653201 https://www.quantisnow.com/insight/fda-approval-for-hetlioz-issued-to-vanda-pharms-inc-6653201 Wed, 29 Jul 2026 18:29:29 GMT Submission status for OUTLOOK THERAPEUTICS, INC.'s drug LYTENAVA (ORIG-1) with active ingredient BEVACIZUMAB-VIKG has changed to 'Approval' on 07/24/2026. Application Category: BLA, Application Number: 761320, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-lytenava-issued-to-outlook-therapeutics-inc-6649440 https://www.quantisnow.com/insight/fda-approval-for-lytenava-issued-to-outlook-therapeutics-inc-6649440 Mon, 27 Jul 2026 16:53:57 GMT Submission status for SANOFI AVENTIS US's drug AVAPRO (SUPPL-81) with active ingredient IRBESARTAN has changed to 'Approval' on 07/24/2026. Application Category: NDA, Application Number: 020757, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-avapro-issued-to-sanofi-aventis-us-6648789 https://www.quantisnow.com/insight/fda-approval-for-avapro-issued-to-sanofi-aventis-us-6648789 Mon, 27 Jul 2026 08:50:56 GMT Submission status for NUVALENT INC's drug JIDEYTRO (ORIG-1) with active ingredient ZIDESAMTINIB has changed to 'Approval' on 07/22/2026. Application Category: NDA, Application Number: 220185, Application Classification: Type 1 - New Molecular Entity https://www.quantisnow.com/insight/fda-approval-for-jideytro-issued-to-nuvalent-inc-6647816 https://www.quantisnow.com/insight/fda-approval-for-jideytro-issued-to-nuvalent-inc-6647816 Fri, 24 Jul 2026 10:38:55 GMT Submission status for LANNETT CO INC's drug METHADONE HYDROCHLORIDE (SUPPL-1) with active ingredient METHADONE HYDROCHLORIDE has changed to 'Approval' on 07/17/2026. Application Category: ANDA, Application Number: 212093, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-methadone-hydrochloride-issued-to-lannett-co-inc-6644361 https://www.quantisnow.com/insight/fda-approval-for-methadone-hydrochloride-issued-to-lannett-co-inc-6644361 Wed, 22 Jul 2026 08:48:32 GMT Submission status for LANNETT CO INC's drug METHADONE HYDROCHLORIDE (SUPPL-7) with active ingredient METHADONE HYDROCHLORIDE has changed to 'Approval' on 07/17/2026. Application Category: ANDA, Application Number: 212093, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-methadone-hydrochloride-issued-to-lannett-co-inc-6644360 https://www.quantisnow.com/insight/fda-approval-for-methadone-hydrochloride-issued-to-lannett-co-inc-6644360 Wed, 22 Jul 2026 08:48:32 GMT Submission status for LANNETT CO INC's drug METHADONE HYDROCHLORIDE (SUPPL-2) with active ingredient METHADONE HYDROCHLORIDE has changed to 'Approval' on 07/17/2026. Application Category: ANDA, Application Number: 212093, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-methadone-hydrochloride-issued-to-lannett-co-inc-6644359 https://www.quantisnow.com/insight/fda-approval-for-methadone-hydrochloride-issued-to-lannett-co-inc-6644359 Wed, 22 Jul 2026 08:48:32 GMT Submission status for LANNETT CO INC's drug METHADONE HYDROCHLORIDE (SUPPL-6) with active ingredient METHADONE HYDROCHLORIDE has changed to 'Approval' on 07/17/2026. Application Category: ANDA, Application Number: 212093, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-methadone-hydrochloride-issued-to-lannett-co-inc-6644358 https://www.quantisnow.com/insight/fda-approval-for-methadone-hydrochloride-issued-to-lannett-co-inc-6644358 Wed, 22 Jul 2026 08:48:32 GMT Submission status for CELCUITY INC..'s drug REVTORPYK (ORIG-1) with active ingredient GEDATOLISIB has changed to 'Approval' on 07/14/2026. Application Category: NDA, Application Number: 219908, Application Classification: Type 1 - New Molecular Entity https://www.quantisnow.com/insight/fda-approval-for-revtorpyk-issued-to-celcuity-inc-6638130 https://www.quantisnow.com/insight/fda-approval-for-revtorpyk-issued-to-celcuity-inc-6638130 Wed, 15 Jul 2026 19:03:57 GMT Submission status for AMGEN INC's drug REPATHA (SUPPL-49) with active ingredient EVOLOCUMAB has changed to 'Approval' on 07/15/2026. Application Category: BLA, Application Number: 125522, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-repatha-issued-to-amgen-inc-6637982 https://www.quantisnow.com/insight/fda-approval-for-repatha-issued-to-amgen-inc-6637982 Wed, 15 Jul 2026 14:42:34 GMT Submission status for SANOFI-AVENTIS U.S. LLC's drug SARCLISA ESCENA (ORIG-1) with active ingredient ISATUXIMAB-IRFC has changed to 'Approval' on 07/09/2026. Application Category: BLA, Application Number: 761445, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-sarclisa-escena-issued-to-sanofi-aventis-us-llc-6635207 https://www.quantisnow.com/insight/fda-approval-for-sarclisa-escena-issued-to-sanofi-aventis-us-llc-6635207 Mon, 13 Jul 2026 18:11:56 GMT Submission status for VERA THERAPEUTICS INC.'s drug TRUTAKNA (ORIG-1) with active ingredient ATACIEPT-VYMJ has changed to 'Approval' on 07/07/2026. Application Category: BLA, Application Number: 761486, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-trutakna-issued-to-vera-therapeutics-inc-6631394 https://www.quantisnow.com/insight/fda-approval-for-trutakna-issued-to-vera-therapeutics-inc-6631394 Wed, 08 Jul 2026 18:50:02 GMT Submission status for VIRIDIAN THERAPEUTICS INC's drug LUMVOA (ORIG-1) with active ingredient VELIGROTUG-VVZE has changed to 'Approval' on 06/26/2026. Application Category: BLA, Application Number: 761530, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-lumvoa-issued-to-viridian-therapeutics-inc-6620488 https://www.quantisnow.com/insight/fda-approval-for-lumvoa-issued-to-viridian-therapeutics-inc-6620488 Tue, 30 Jun 2026 16:20:03 GMT Submission status for INSMED INC's drug ARIKAYCE KIT (SUPPL-25) with active ingredient AMIKACIN SULFATE has changed to 'Approval' on 06/25/2026. Application Category: NDA, Application Number: 207356, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-arikayce-kit-issued-to-insmed-inc-6617987 https://www.quantisnow.com/insight/fda-approval-for-arikayce-kit-issued-to-insmed-inc-6617987 Mon, 29 Jun 2026 08:48:07 GMT Submission status for ABBVIE INC's drug SKYRIZI (SUPPL-16) with active ingredient RISANKIZUMAB-RZAA has changed to 'Approval' on 06/26/2026. Application Category: BLA, Application Number: 761262, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-skyrizi-issued-to-abbvie-inc-6617986 https://www.quantisnow.com/insight/fda-approval-for-skyrizi-issued-to-abbvie-inc-6617986 Mon, 29 Jun 2026 08:48:07 GMT Submission status for SANOFI AVENTIS US's drug SARCLISA (SUPPL-18) with active ingredient ISATUXIMAB-IRFC has changed to 'Approval' on 06/26/2026. Application Category: BLA, Application Number: 761113, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-sarclisa-issued-to-sanofi-aventis-us-6617985 https://www.quantisnow.com/insight/fda-approval-for-sarclisa-issued-to-sanofi-aventis-us-6617985 Mon, 29 Jun 2026 08:48:07 GMT Submission status for ABBVIE INC's drug SKYRIZI (SUPPL-45) with active ingredient RISANKIZUMAB-RZAA has changed to 'Approval' on 06/26/2026. Application Category: BLA, Application Number: 761105, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-skyrizi-issued-to-abbvie-inc-6617984 https://www.quantisnow.com/insight/fda-approval-for-skyrizi-issued-to-abbvie-inc-6617984 Mon, 29 Jun 2026 08:48:07 GMT Submission status for IMMUNOMEDICS INC's drug TRODELVY (SUPPL-63) with active ingredient SACITUZUMAB GOVITECAN-HZIY has changed to 'Approval' on 06/24/2026. Application Category: BLA, Application Number: 761115, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-trodelvy-issued-to-immunomedics-inc-6614914 https://www.quantisnow.com/insight/fda-approval-for-trodelvy-issued-to-immunomedics-inc-6614914 Thu, 25 Jun 2026 08:48:53 GMT Submission status for IONIS PHARMS INC's drug TRYNGOLZA (AUTOINJECTOR) (SUPPL-4) with active ingredient OLEZARSEN SODIUM has changed to 'Approval' on 06/24/2026. Application Category: NDA, Application Number: 218614, Application Classification: Efficacy https://www.quantisnow.com/insight/fda-approval-for-tryngolza-autoinjector-issued-to-ionis-pharms-inc-6614913 https://www.quantisnow.com/insight/fda-approval-for-tryngolza-autoinjector-issued-to-ionis-pharms-inc-6614913 Thu, 25 Jun 2026 08:48:53 GMT Submission status for IMMUNOMEDICS INC's drug TRODELVY (SUPPL-64) with active ingredient SACITUZUMAB GOVITECAN-HZIY has changed to 'Approval' on 06/24/2026. Application Category: BLA, Application Number: 761115, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-trodelvy-issued-to-immunomedics-inc-6614912 https://www.quantisnow.com/insight/fda-approval-for-trodelvy-issued-to-immunomedics-inc-6614912 Thu, 25 Jun 2026 08:48:53 GMT Submission status for LANNETT CO INC's drug HYDROCODONE BITARTRATE AND ACETAMINOPHEN (SUPPL-14) with active ingredient ACETAMINOPHEN; HYDROCODONE BITARTRATE has changed to 'Approval' on 06/18/2026. Application Category: ANDA, Application Number: 207172, Application Classification: REMS https://www.quantisnow.com/insight/fda-approval-for-hydrocodone-bitartrate-and-acetaminophen-issued-to-lannett-6609675 https://www.quantisnow.com/insight/fda-approval-for-hydrocodone-bitartrate-and-acetaminophen-issued-to-lannett-6609675 Fri, 19 Jun 2026 08:55:22 GMT 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 https://www.quantisnow.com/insight/fda-approval-for-oxycodone-and-acetaminophen-issued-to-lannett-co-6609674 https://www.quantisnow.com/insight/fda-approval-for-oxycodone-and-acetaminophen-issued-to-lannett-co-6609674 Fri, 19 Jun 2026 08:55:26 GMT Submission status for LANNETT CO INC's drug HYDROCODONE BITARTRATE AND ACETAMINOPHEN (SUPPL-14) with active ingredient ACETAMINOPHEN; HYDROCODONE BITARTRATE has changed to 'Approval' on 06/18/2026. Application Category: ANDA, Application Number: 207171, Application Classification: REMS https://www.quantisnow.com/insight/fda-approval-for-hydrocodone-bitartrate-and-acetaminophen-issued-to-lannett-6609673 https://www.quantisnow.com/insight/fda-approval-for-hydrocodone-bitartrate-and-acetaminophen-issued-to-lannett-6609673 Fri, 19 Jun 2026 08:55:20 GMT 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 https://www.quantisnow.com/insight/fda-approval-for-oxycodone-hydrochloride-issued-to-lannett-co-inc-6609672 https://www.quantisnow.com/insight/fda-approval-for-oxycodone-hydrochloride-issued-to-lannett-co-inc-6609672 Fri, 19 Jun 2026 08:54:17 GMT 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 https://www.quantisnow.com/insight/fda-approval-for-codeine-sulfate-issued-to-lannett-co-inc-6609671 https://www.quantisnow.com/insight/fda-approval-for-codeine-sulfate-issued-to-lannett-co-inc-6609671 Fri, 19 Jun 2026 08:54:10 GMT 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 https://www.quantisnow.com/insight/fda-approval-for-rextovy-issued-to-amphastar-pharms-inc-6604038 https://www.quantisnow.com/insight/fda-approval-for-rextovy-issued-to-amphastar-pharms-inc-6604038 Tue, 16 Jun 2026 12:20:56 GMT 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: https://www.quantisnow.com/insight/fda-approval-for-skyrizi-issued-to-abbvie-inc-6603694 https://www.quantisnow.com/insight/fda-approval-for-skyrizi-issued-to-abbvie-inc-6603694 Tue, 16 Jun 2026 08:45:14 GMT 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: https://www.quantisnow.com/insight/fda-approval-for-skyrizi-issued-to-abbvie-inc-6603693 https://www.quantisnow.com/insight/fda-approval-for-skyrizi-issued-to-abbvie-inc-6603693 Tue, 16 Jun 2026 08:45:14 GMT 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: https://www.quantisnow.com/insight/fda-approval-for-tzield-issued-to-provention-bio-inc-6602034 https://www.quantisnow.com/insight/fda-approval-for-tzield-issued-to-provention-bio-inc-6602034 Mon, 15 Jun 2026 12:33:18 GMT 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: https://www.quantisnow.com/insight/fda-approval-for-tzield-issued-to-provention-bio-inc-6602033 https://www.quantisnow.com/insight/fda-approval-for-tzield-issued-to-provention-bio-inc-6602033 Mon, 15 Jun 2026 12:33:18 GMT