FDANews

LLY$1041.29▲ 0.28%
NVO$60.68▼ 2.65%
JNJ$218.21▼ 0.21%
MRK$109.45▲ 0.57%
ABBV$214.04▼ 0.14%
PFE$25.52▼ 0.51%
AMGN$331.00▲ 0.18%
VRTX$442.08▲ 0.16%
GILD$124.14▼ 0.62%
REGN$733.78▲ 0.10%
LLY$1041.29▲ 0.28%
NVO$60.68▼ 2.65%
JNJ$218.21▼ 0.21%
MRK$109.45▲ 0.57%
ABBV$214.04▼ 0.14%
PFE$25.52▼ 0.51%
AMGN$331.00▲ 0.18%
VRTX$442.08▲ 0.16%
GILD$124.14▼ 0.62%
REGN$733.78▲ 0.10%

Recent FDA Approvals

Latest drug approvals and regulatory decisions

Approved

BRIUMVI

UBLITUXIMAB-XIIY

Sponsor TG THERAPEUTICS, INC
Decision Date Aug 18, 2025
Application NDA #BLA761238
Approved

LOSARTAN POTASSIUM

LOSARTAN POTASSIUM

Sponsor HIKMA
Decision Date Sep 26, 2014
Application NDA #ANDA077459
Approved

IMPLANON

ETONOGESTREL

Sponsor ORGANON
Decision Date Jan 18, 2007
Application NDA #NDA021529
Approved

METHYLPHENIDATE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE

Sponsor MOUNTAIN
Decision Date Jan 15, 2026
Application NDA #ANDA091159
Approved

OSELTAMIVIR PHOSPHATE

OSELTAMIVIR PHOSPHATE

Sponsor AJANTA PHARMA LTD
Decision Date Jan 15, 2026
Application NDA #ANDA212784
Approved

OXALIPLATIN

OXALIPLATIN

Sponsor SHANDONG
Decision Date Jan 15, 2026
Application NDA #ANDA219765
Approved

FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE

Sponsor AUROBINDO PHARMA LTD
Decision Date Jun 10, 2020
Application NDA #ANDA213265
Approved

FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE

Sponsor AUROBINDO PHARMA LTD
Decision Date Aug 18, 2023
Application NDA #ANDA213286
Approved

OTULFI

USTEKINUMAB-AAUZ

Sponsor FRESENIUS KABI USA
Decision Date Apr 30, 2025
Application NDA #BLA761379
Approved

NAPROXEN SODIUM

NAPROXEN SODIUM

Sponsor BIONPHARMA
Decision Date Nov 29, 2018
Application NDA #NDA021920
Approved

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE

Sponsor WATSON LABS
Decision Date May 07, 2020
Application NDA #ANDA200180
Approved

ALVAIZ

ELTROMBOPAG CHOLINE

Sponsor TEVA PHARMS INC
Decision Date Jan 15, 2026
Application NDA #NDA216774
Approved

REZUROCK

BELUMOSUDIL MESYLATE

Sponsor KADMON PHARMS LLC
Decision Date Jul 16, 2021
Application NDA #NDA214783
Approved

MYCOPHENOLATE MOFETIL

MYCOPHENOLATE MOFETIL

Sponsor AUROBINDO PHARMA
Decision Date Aug 13, 2024
Application NDA #ANDA217937
Approved

GABAPENTIN

GABAPENTIN

Sponsor LAURUS
Decision Date Dec 31, 2024
Application NDA #ANDA217546
Approved

ELTROMBOPAG OLAMINE

ELTROMBOPAG OLAMINE

Sponsor AMNEAL
Decision Date Jan 14, 2026
Application NDA #ANDA212884
Approved

LIRAGLUTIDE

LIRAGLUTIDE

Sponsor ORBICULAR
Decision Date Jan 14, 2026
Application NDA #ANDA217590
Approved

ROGAINE (FOR WOMEN)

MINOXIDIL

Sponsor KENVUE BRANDS
Decision Date Aug 24, 1988
Application NDA #NDA019501
Approved

ELTROMBOPAG OLAMINE

ELTROMBOPAG OLAMINE

Sponsor MSN
Decision Date Jan 14, 2026
Application NDA #ANDA220250
Approved

AVTOZMA

TOCILIZUMAB-ANOH

Sponsor CELLTRION INC
Decision Date Jan 14, 2026
Application NDA #BLA761420

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