Every original FDA approval from the last 60 days - new drugs, biologics and generics - with sponsor, active ingredient and review priority. The free tracker for what's newly approvable in the world's largest pharma market.
| Approved | Product | Type | Sponsor |
|---|---|---|---|
| 25 Sep 2026 | DEGEVMA | Biologic (BLA) | Teva Pharmaceuticals, Inc. |
| 25 Sep 2026 | METRONIDAZOLE 17 clinical trials → | Generic (ANDA) | Aurobindo Pharma Ltd |
| 11 Sep 2026 | ISEMBYLD | Biologic (BLA)Priority | Scholar Rock Inc |
| 08 Sep 2026 | BRIVARACETAM 2 clinical trials → | Generic (ANDA) | Zhejiang Jutai Pharm |
| 03 Sep 2026 | TESTOSTERONE CYPIONATE 2 clinical trials → | Generic (ANDA) | Bpi Labs |
| 31 Aug 2026 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 20 clinical trials → | Generic (ANDA) | Macleods Pharms Ltd |
| 27 Aug 2026 | LISRAYA 2 clinical trials → | New Drug (NDA)Priority | Priovant Therap |
| 21 Aug 2026 | NITROGLYCERIN 6 clinical trials → | Generic (ANDA) | Socorro N1 |
| 19 Aug 2026 | NINTEDANIB ESYLATE | Generic (ANDA) | Biocon Pharma |
| 19 Aug 2026 | PASATRU | Biologic (BLA)Priority | Regeneron Pharmaceuticals, Inc |
| 14 Aug 2026 | PITOLISANT HYDROCHLORIDE 6 clinical trials → | Generic (ANDA) | Msn |
| 14 Aug 2026 | PROPRANOLOL HYDROCHLORIDE 24 clinical trials → | Generic (ANDA) | Creekwood Pharms |
| 11 Aug 2026 | TRIAMCINOLONE ACETONIDE 12 clinical trials → | Generic (ANDA) | Aurobindo Pharma Ltd |
| 24 Jul 2026 | GARZULYS | Biologic (BLA) | Emerge Bioscience Pte. Ltd. |
| 16 Jun 2026 | ATOMOXETINE HYDROCHLORIDE 3 clinical trials → | Generic (ANDA) | Pharmazone |
| 21 Jan 2026 | AVTOZMA | Biologic (BLA) | Celltrion Inc |
| 18 Dec 2025 | BUPRENORPHINE HYDROCHLORIDE 6 clinical trials → | Generic (ANDA) | Ascent Pharms Inc |
| 10 Dec 2025 | BUPRENORPHINE HYDROCHLORIDE 6 clinical trials → | Generic (ANDA) | Specgx Llc |
| 25 Sep 2025 | INLURIYO 8 clinical trials → | New Drug (NDA) | Eli Lilly And Co |
| 29 Apr 2025 | IMAAVY | Biologic (BLA)Priority | Janssen Biotech |
| 22 Apr 2025 | SIPONIMOD 3 clinical trials → | Generic (ANDA) | Riconpharma Llc |
| 14 May 2024 | ACETAZOLAMIDE 11 clinical trials → | Generic (ANDA) | Epic Pharma Llc |
| 03 Nov 2023 | ZITUVIMET 96 clinical trials → | New Drug (NDA) | Zydus Lifesciences |
| 02 Jun 2023 | EPLERENONE 6 clinical trials → | Generic (ANDA) | Annora Pharma |
| 12 Dec 2022 | KRAZATI 14 clinical trials → | New Drug (NDA) | Bristol |
| 19 Aug 2022 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Vistapharm Llc |
| 22 Feb 2022 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Sciegen Pharms |
| 14 Jan 2022 | CIBINQO 10 clinical trials → | New Drug (NDA)Priority | Pfizer |
| 12 Jan 2021 | FOSAPREPITANT DIMEGLUMINE | Generic (ANDA) | Eugia Pharma |
| 06 Nov 2020 | METOPROLOL SUCCINATE 5 clinical trials → | Generic (ANDA) | Hetero Labs Ltd Iii |
| 25 Sep 2020 | XELJANZ 32 clinical trials → | New Drug (NDA)Priority | Pfizer |
| 29 Jul 2020 | METHYLPHENIDATE HYDROCHLORIDE 12 clinical trials → | Generic (ANDA) | Granules |
| 03 Mar 2020 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Saptalis Pharms |
| 03 Dec 2019 | GABAPENTIN 10 clinical trials → | Generic (ANDA) | Pai Holdings Pharm |
| 27 Nov 2019 | CELECOXIB 26 clinical trials → | Generic (ANDA) | Pharmazone |
| 05 Sep 2019 | FOSAPREPITANT DIMEGLUMINE | Generic (ANDA) | Msn |
| 21 Jun 2019 | DEXTROAMPHETAMINE SULFATE | Generic (ANDA) | Strides Pharma |
| 26 Mar 2019 | TADALAFIL 16 clinical trials → | Generic (ANDA) | Sun Pharm |
| 15 Feb 2019 | TYZAVAN 21 clinical trials → | New Drug (NDA)Priority | Hikma |
| 27 Dec 2018 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Qingdao Baheal Pharm |
| 10 Aug 2018 | ANNOVERA | New Drug (NDA) | Mayne Pharma |
| 08 Aug 2018 | JORNAY PM 12 clinical trials → | New Drug (NDA) | Ironshore Pharms |
| 19 Mar 2018 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Alignscience Pharma |
| 16 Mar 2018 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Granules |
| 05 Dec 2017 | OZEMPIC 124 clinical trials → | New Drug (NDA) | Novo |
| 29 Sep 2017 | ISOTRETINOIN 10 clinical trials → | Generic (ANDA) | Amneal Pharms Ny |
| 20 Jul 2017 | BENLYSTA 13 clinical trials → | Biologic (BLA) | Glaxosmithkline Llc |
| 01 May 2017 | IMFINZI 218 clinical trials → | Biologic (BLA)Priority | Astrazeneca Uk Ltd |
| 23 Mar 2017 | BAVENCIO 34 clinical trials → | Biologic (BLA)Priority | Emd Serono Inc |
| 13 Dec 2016 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Regcon Holdings |
| 23 Sep 2016 | STELARA 25 clinical trials → | Biologic (BLA) | Janssen Biotech |
| 20 Sep 2016 | INVOKAMET XR 7 clinical trials → | New Drug (NDA) | Janssen Pharms |
| 24 Aug 2016 | POLYETHYLENE GLYCOL 3350 | Generic (ANDA) | Strides Pharma |
| 11 Jul 2016 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Cspc Ouyi |
| 19 Sep 2014 | PENTOSTATIN | Generic (ANDA) | Rising |
| 08 Sep 2014 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 6 clinical trials → | Generic (ANDA) | Teva Pharms Usa |
| 08 Aug 2014 | INVOKAMET 7 clinical trials → | New Drug (NDA) | Janssen Pharms |
| 20 Mar 2014 | INDOMETHACIN 6 clinical trials → | Generic (ANDA) | Mylan |
| 03 Feb 2014 | PRIMAQUINE PHOSPHATE 2 clinical trials → | Generic (ANDA) | Alvogen |
| 25 Jul 2013 | INJECTAFER 9 clinical trials → | New Drug (NDA) | Am Regent |
| 14 Jun 2013 | TRANEXAMIC ACID 44 clinical trials → | Generic (ANDA) | Pharmobedient |
| 25 Mar 2013 | ZENATANE 10 clinical trials → | Generic (ANDA) | Dr Reddys Labs Ltd |
| 22 Feb 2013 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 6 clinical trials → | Generic (ANDA) | Actavis Elizabeth |
| 01 Aug 2012 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Mylan Pharms Inc |
| 20 Jul 2012 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Aurobindo Pharma Ltd |
| 14 Jul 2011 | ACETAZOLAMIDE 11 clinical trials → | Generic (ANDA) | Indicus Pharma |
| 05 Nov 2010 | KOMBIGLYZE XR 96 clinical trials → | New Drug (NDA) | Astrazeneca Ab |
| 06 Oct 2010 | LOSARTAN POTASSIUM 11 clinical trials → | Generic (ANDA) | Watson Labs |
| 30 Aug 2010 | SUBOXONE 6 clinical trials → | New Drug (NDA) | Indivior |
| 02 Jul 2010 | SPIRONOLACTONE 16 clinical trials → | Generic (ANDA) | Amneal Pharms |
| 24 Mar 2010 | ROPINIROLE HYDROCHLORIDE | Generic (ANDA) | Alembic Ltd |
| 25 Sep 2009 | STELARA 25 clinical trials → | Biologic (BLA) | Centocor Ortho Biotech Inc |
| 26 Aug 2009 | CLINDAMYCIN HYDROCHLORIDE 7 clinical trials → | Generic (ANDA) | Aurobindo Pharma |
| 24 Feb 2009 | RISPERIDONE 8 clinical trials → | Generic (ANDA) | Senores Pharms |
| 25 Nov 2008 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Indicus Pharma |
| 28 Oct 2008 | CARBIDOPA AND LEVODOPA 2 clinical trials → | Generic (ANDA) | Sun Pharm Inds |
| 01 Aug 2008 | EPLERENONE 6 clinical trials → | Generic (ANDA) | Sandoz |
| 09 Jun 2008 | RAMIPRIL 7 clinical trials → | Generic (ANDA) | Lupin |
| 11 Mar 2008 | MINOCYCLINE HYDROCHLORIDE 6 clinical trials → | Generic (ANDA) | Aurobindo Pharma |
| 11 Jan 2008 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Sun Pharm Inds Inc |
| 29 Aug 2006 | SPIRONOLACTONE 16 clinical trials → | Generic (ANDA) | Oxford Pharms |
| 26 Jul 2006 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Nostrum Pharms Llc |
| 09 Feb 2006 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Sun Pharm Inds (in) |
| 18 Apr 2005 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Zydus Pharms Usa |
| 01 Oct 2004 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Actavis Elizabeth |
| 16 Jun 2004 | CARBIDOPA AND LEVODOPA 2 clinical trials → | Generic (ANDA) | Apotex |
| 16 Mar 2004 | CHILDREN'S ZYRTEC ALLERGY 2 clinical trials → | New Drug (NDA) | Kenvue Brands |
| 21 Aug 2003 | DIGOXIN 8 clinical trials → | Generic (ANDA) | Sandoz |
| 23 Apr 2002 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Apotex |
| 29 Jan 2002 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Sun Pharm Inds Inc |
| 29 Jan 2002 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Pharmobedient |
| 25 Jan 2002 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Epic Pharma Llc |
| 25 Jan 2002 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Mylan |
| 25 Jan 2002 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Heritage Pharma |
| 25 Jan 2002 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Sandoz |
| 24 Jan 2002 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Chartwell |
| 24 Jan 2002 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Pharmobedient |
| 24 Jan 2002 | METFORMIN HYDROCHLORIDE 96 clinical trials → | Generic (ANDA) | Watson Labs |
| 17 May 1996 | ETOPOPHOS PRESERVATIVE FREE 163 clinical trials → | New Drug (NDA) | Cheplapharm |
| 21 May 1971 | RIMACTANE 7 clinical trials → | New Drug (NDA) | Oxford Pharms |
Source: openFDA Drugs@FDA API, U.S. Food & Drug Administration - original (ORIG) approvals only; supplement approvals excluded. openFDA data is provided as-is and unvalidated. Compare the EU market in our EMA Approvals Tracker, see the FDA Recall Tracker for enforcement reports, or cross-reference the Irish market in the Irish Medicines Database.
