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 |
|---|---|---|---|
| 11 Aug 2026 | VALSARTAN
VALSARTAN · Tablet |
Generic (ANDA) | Bostal Drug |
| 04 Aug 2026 | SACUBITRIL AND VALSARTAN
SACUBITRIL, VALSARTAN · Tablet |
Generic (ANDA) | Umedica |
| 04 Aug 2026 | NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
NICARDIPINE HYDROCHLORIDE · Injectable |
Generic (ANDA) | Fresenius Kabi Usa |
| 31 Jul 2026 | ATROPINE SULFATE
ATROPINE SULFATE · Solution/drops |
Generic (ANDA) | Gland |
| 31 Jul 2026 | DOCOSANOL
DOCOSANOL · Cream |
Generic (ANDA) | Klm Labs Pvt |
| 28 Jul 2026 | GWYN LO
ETHINYL ESTRADIOL, NORELGESTROMIN · System |
New Drug (NDA) | Viatris Specialty |
| 28 Jul 2026 | SUGAMMADEX SODIUM
SUGAMMADEX SODIUM · Solution |
Generic (ANDA) | Steriscience |
| 28 Jul 2026 | SUGAMMADEX SODIUM
SUGAMMADEX SODIUM · Solution |
Generic (ANDA) | Teva Pharms Usa Inc |
| 24 Jul 2026 | GARZULYS
INSULIN ASPART-FSAN · Vial |
Biologic (BLA) | Emerge Bioscience Pte. Ltd. |
| 24 Jul 2026 | TYLENOL WITH NAPROXEN
ACETAMINOPHEN, NAPROXEN SODIUM · Tablet |
New Drug (NDA) | Kenvue Brands |
| 22 Jul 2026 | EDARAVONE
EDARAVONE · Solution |
Generic (ANDA) | Zydus Pharms |
| 09 Jul 2026 | MAGNESIUM SULFATE
MAGNESIUM SULFATE · Solution |
Generic (ANDA) | Square Pharms Plc |
| 08 Jul 2026 | DAPSONE
DAPSONE · Tablet |
Generic (ANDA) | Macleods Pharms |
| 07 Jul 2026 | TRUTAKNA
ATACICEPT-VYMJ · Injectable |
Biologic (BLA)Priority | Vera Therapeutics Inc. |
| 01 Jul 2026 | LIRAGLUTIDE
LIRAGLUTIDE · Solution |
Generic (ANDA) | Sandoz |
| 01 Jul 2026 | BRIVARACETAM
BRIVARACETAM · Tablet |
Generic (ANDA) | Sciegen Pharms |
| 01 Jul 2026 | CHLORTHALIDONE
CHLORTHALIDONE · Tablet |
Generic (ANDA) | Macleods Pharms |
| 30 Jun 2026 | SELENIOUS ACID
SELENIOUS ACID · Solution |
Generic (ANDA) | Zydus Pharms |
| 29 Jun 2026 | POSACONAZOLE
POSACONAZOLE · Tablet, Delayed Release |
Generic (ANDA) | Apotex |
| 26 Jun 2026 | LUMVOA
VELIGROTUG-VVZE · Injection |
Biologic (BLA)Priority | Viridian Therapeutics Inc |
| 25 Jun 2026 | FERRIC CARBOXYMALTOSE
FERRIC CARBOXYMALTOSE · Solution |
Generic (ANDA) | Mylan |
| 25 Jun 2026 | FERRIC CARBOXYMALTOSE
FERRIC CARBOXYMALTOSE · Solution |
Generic (ANDA) | Mylan Labs Ltd |
| 23 Jun 2026 | RIFAPENTINE
RIFAPENTINE · Tablet |
Generic (ANDA) | Macleods Pharms |
| 22 Jun 2026 | LO JUNEL FE
ETHINYL ESTRADIOL, NORETHINDRONE ACETATE · Tablet |
Generic (ANDA) | Teva Pharms Inc |
| 18 Dec 2025 | BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Ascent Pharms Inc |
| 07 Aug 2025 | OMEPRAZOLE MAGNESIUM
OMEPRAZOLE MAGNESIUM · Tablet, Delayed Release |
Generic (ANDA) | Marksans Pharma |
| 09 Jun 2025 | ROCURONIUM BROMIDE
ROCURONIUM BROMIDE · Solution |
New Drug (NDA) | Fresenius Kabi Usa |
| 17 Apr 2025 | ELIQUIS
APIXABAN · Suspension |
New Drug (NDA)Priority | Bristol |
| 14 Feb 2025 | ROMVIMZA
VIMSELTINIB · Capsule |
New Drug (NDA)Priority | Deciphera Pharms |
| 06 Nov 2024 | ROSUVASTATIN CALCIUM
ROSUVASTATIN CALCIUM · Tablet |
Generic (ANDA) | Macleods Pharms |
| 10 Jun 2024 | IQIRVO
ELAFIBRANOR · Tablet |
New Drug (NDA)Priority | Ipsen |
| 26 Apr 2024 | RINVOQ LQ
UPADACITINIB · Solution |
New Drug (NDA) | Abbvie |
| 29 Nov 2023 | MYCOPHENOLATE SODIUM
MYCOPHENOLATE SODIUM · Tablet, Delayed Release |
Generic (ANDA) | Biocon Pharma |
| 26 May 2023 | INPEFA
SOTAGLIFLOZIN · Tablet |
New Drug (NDA) | Lexicon Pharms Inc |
| 07 Jun 2022 | NAPROXEN
NAPROXEN · Suspension |
Generic (ANDA) | Hetero Labs Ltd Iii |
| 17 Mar 2022 | LACOSAMIDE
LACOSAMIDE · Tablet |
Generic (ANDA) | Msn Labs Pvt Ltd |
| 03 Dec 2021 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet |
Generic (ANDA) | Harman Finochem |
| 11 Aug 2021 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Unichem |
| 03 Aug 2021 | IBUPROFEN AND FAMOTIDINE
FAMOTIDINE, IBUPROFEN · Tablet |
Generic (ANDA) | Alkem Labs Ltd |
| 29 Jul 2021 | MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL · For Suspension |
Generic (ANDA) | Quagen |
| 26 Jul 2021 | HALOPERIDOL DECANOATE
HALOPERIDOL DECANOATE · Injectable |
Generic (ANDA) | Meitheal |
| 15 Jun 2021 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Alkem Labs Ltd |
| 01 Jun 2021 | BREXAFEMME
IBREXAFUNGERP CITRATE · Tablet |
New Drug (NDA)Priority | Glaxosmithkline |
| 23 Dec 2020 | FENOFIBRIC ACID
CHOLINE FENOFIBRATE · Capsule, Delayed Release |
Generic (ANDA) | Yichang Humanwell |
| 04 Aug 2020 | XTANDI
ENZALUTAMIDE · Tablet |
New Drug (NDA) | Astellas |
| 10 Jul 2020 | ACYCLOVIR
ACYCLOVIR · Suspension |
Generic (ANDA) | Novitium Pharma |
| 14 May 2020 | DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE · Tablet |
Generic (ANDA) | Alembic |
| 14 Jun 2019 | DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE · Capsule, Extended Release |
Generic (ANDA) | Novast Labs |
| 26 Mar 2019 | MAYZENT
SIPONIMOD · Tablet |
New Drug (NDA)Priority | Novartis |
| 08 Jan 2019 | MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL · Capsule |
Generic (ANDA) | Concord Biotech Ltd |
| 28 Nov 2018 | TRUXIMA
RITUXIMAB-ABBS · Injectable |
Biologic (BLA) | Celltrion Inc |
| 20 Nov 2018 | BUPRENORPHINE
BUPRENORPHINE · Film, Extended Release |
Generic (ANDA) | Watson Labs Teva |
| 22 Oct 2018 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Alkem Labs Ltd |
| 14 Jun 2018 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE · Film |
Generic (ANDA) | Dr Reddys Labs Sa |
| 13 Jun 2018 | DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE · Capsule |
Generic (ANDA) | Alembic |
| 20 Mar 2018 | ILUMYA
TILDRAKIZUMAB-ASMN · Injectable |
Biologic (BLA) | Sun Pharma Global |
| 29 Dec 2017 | PIROXICAM
PIROXICAM · Capsule |
Generic (ANDA) | Micro Labs |
| 31 Oct 2017 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet |
Generic (ANDA) | Aarxion Anda Hlding |
| 13 Jul 2017 | EPLERENONE
EPLERENONE · Tablet |
Generic (ANDA) | Accord Hlthcare |
| 07 Jun 2017 | NORVIR
RITONAVIR · Powder |
New Drug (NDA)Priority | Abbvie |
| 11 May 2017 | METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Abhai Llc |
| 28 Apr 2017 | AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE · Spray, Metered |
Generic (ANDA) | Apotex |
| 27 Mar 2017 | BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Rhodes Pharms |
| 22 Feb 2017 | LINEZOLID
LINEZOLID · Tablet |
Generic (ANDA) | Zydus Pharms |
| 27 Jun 2016 | DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE · Capsule |
Generic (ANDA) | Amneal Pharms |
| 11 Apr 2016 | GEMCITABINE HYDROCHLORIDE
GEMCITABINE HYDROCHLORIDE · Injectable |
Generic (ANDA) | Actavis Inc |
| 11 Dec 2015 | ALECENSA
ALECTINIB HYDROCHLORIDE · Capsule |
New Drug (NDA)Priority | Hoffmann-la Roche |
| 26 Aug 2015 | SYNJARDY
EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE · Tablet |
New Drug (NDA) | Boehringer Ingelheim |
| 15 Dec 2014 | MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL · Tablet |
Generic (ANDA) | Jubilant Cadista |
| 25 Jan 2013 | KAZANO
ALOGLIPTIN BENZOATE, METFORMIN HYDROCHLORIDE · Tablet |
New Drug (NDA) | Takeda Pharms Usa |
| 14 Nov 2012 | IRBESARTAN
IRBESARTAN · Tablet |
Generic (ANDA) | Chartwell Molecular |
| 31 Aug 2012 | XTANDI
ENZALUTAMIDE · Capsule |
New Drug (NDA)Priority | Astellas |
| 30 Aug 2012 | ALFUZOSIN HYDROCHLORIDE
ALFUZOSIN HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Aurobindo Pharma Ltd |
| 06 Apr 2012 | IMIQUIMOD
IMIQUIMOD · Cream |
Generic (ANDA) | Apotex Inc |
| 18 Jan 2012 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Inventia |
| 29 Jun 2011 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Lupin Ltd |
| 30 Aug 2010 | SUBOXONE
BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE · Film |
New Drug (NDA) | Indivior |
| 10 Feb 2010 | NORVIR
RITONAVIR · Tablet |
New Drug (NDA) | Abbvie |
| 03 Jun 2009 | GLYBURIDE AND METFORMIN HYDROCHLORIDE
GLYBURIDE, METFORMIN HYDROCHLORIDE · Tablet |
Generic (ANDA) | Heritage |
| 04 May 2009 | MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL · Tablet |
Generic (ANDA) | Teva Pharms |
| 15 Oct 2008 | MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL · Tablet |
Generic (ANDA) | Sandoz |
| 05 Aug 2008 | CEFEPIME IN PLASTIC CONTAINER
CEFEPIME HYDROCHLORIDE · Injectable |
New Drug (NDA) | Baxter Hlthcare |
| 06 Aug 2007 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet |
Generic (ANDA) | Ipca Labs Ltd |
| 24 Jan 2006 | GABAPENTIN
GABAPENTIN · Capsule |
Generic (ANDA) | Sandoz |
| 13 Sep 2005 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Pharmobedient |
| 21 Aug 2003 | DIGOXIN
DIGOXIN · Injectable |
Generic (ANDA) | Sandoz |
| 06 May 2003 | DEXTROAMPHETAMINE SULFATE
DEXTROAMPHETAMINE SULFATE · Capsule, Extended Release |
Generic (ANDA) | Specgx Llc |
| 17 Dec 2002 | IDKIT:HP
CITRIC ACID, UREA C-13 · For Solution, Tablet, For Solution |
New Drug (NDA) | Meridian Bioscience |
| 26 Nov 2002 | FORTEO
TERIPARATIDE · Solution |
New Drug (NDA) | Lilly |
| 23 Apr 2002 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet |
Generic (ANDA) | Apotex |
| 25 Jan 2002 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet |
Generic (ANDA) | Heritage Pharma |
| 25 Jan 2002 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet |
Generic (ANDA) | Sandoz |
| 24 Jan 2002 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet |
Generic (ANDA) | Watson Labs |
| 29 Jun 2001 | TRELSTAR
TRIPTORELIN PAMOATE · Injectable |
New Drug (NDA) | Verity |
| 22 Dec 1998 | METHYLPREDNISOLONE
METHYLPREDNISOLONE · Tablet |
Generic (ANDA) | Ph Health |
| 29 Oct 1991 | VALPROIC ACID
VALPROIC ACID · Capsule |
Generic (ANDA) | Catalent |
| 30 Mar 1989 | ELOCON
MOMETASONE FUROATE · Lotion |
New Drug (NDA) | Organon |
| 02 Apr 1987 | LOPURIN
ALLOPURINOL · Tablet |
Generic (ANDA) | Dr Reddys |
| 23 Jul 1986 | SPIRONOLACTONE
SPIRONOLACTONE · Tablet |
Generic (ANDA) | Sun Pharm Industries |
| 28 Apr 1983 | HEPARIN SODIUM
HEPARIN SODIUM · Injectable |
Generic (ANDA) | Hospira |
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.