Apotex
FDA Approves DAPAGLIFLOZIN — Apotex Corp.
The FDA has granted full approval to generic dapagliflozin manufactured by Apotex Corp., paving the way for the company to capture market share in the...
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Aurobindo
FDA Approves DAPAGLIFLOZIN — Aurobindo Pharma Limited
Aurobindo Pharma Limited announced the approval of its ANDA for dapagliflozin, granting it rights to manufacture and market this generic oral product ...
Baxter
FDA Approves PHENYLEPHRINE HYDROCHLORIDE — Baxter Healthcare Corporation
# FDA Approves Baxter Healthcare's Generic Phenylephrine Hydrochloride Injection Baxter Healthcare Corporation has received FDA approval for its gene...
Sandoz
FDA Approves NINTEDANIB — Sandoz Inc
# FDA Approves Sandoz's Generic Nintedanib, Expanding Competition in Pulmonary Fibrosis Market Sandoz Inc. has received FDA approval for its generic ...
Dr.
FDA Approves NINTEDANIB — Dr. Reddy's Laboratories Inc.
# FDA Approves Dr. Reddy's Laboratories' Generic Nintedanib Dr. Reddy's Laboratories Inc. received FDA approval for its generic nintedanib esylate or...
Apotex
FDA Approves NINTEDANIB — Apotex Corp.
# FDA Approves Generic Version of Nintedanib, Enabling Significant Cost Savings for Pulmonary Fibrosis Patients Apotex Corp. has received FDA approva...
EXELAN
FDA Approves NINTEDANIB CAPSULES, 100 MG AND 150 MG — EXELAN PHARMACEUTICALS INC.
# FDA Approves Generic Nintedanib Capsules; Exelan Pharmaceuticals Enters Competitive Pulmonary Fibrosis Market Exelan Pharmaceuticals Inc. has recei...
Edenbridge
FDA Approves NINTEDANIB — Edenbridge Pharmaceuticals LLC.
Edenbridge Pharmaceuticals LLC has received FDA approval for its ANDA219819 application for Nintedanib Esyslate tablets, strengthening the firm’s port...
Eli
FDA Approves FOUNDAYO — Eli Lilly and Company
# FDA Approves Eli Lilly's FOUNDAYO for Oral Administration Eli Lilly and Company received FDA approval for FOUNDAYO (orforglipron calcium), an oral ...
KLM
FDA Approves MESALAMINE — KLM Laboratories Private Limited
# FDA Approves KLM Laboratories' Generic Mesalamine Rectal Formulation KLM Laboratories Private Limited received FDA approval for its generic mesalam...
ScieGen
FDA Approves OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE — ScieGen Pharmaceuticals Inc
# FDA Approves Generic Olmesartan Medoxomil and Hydrochlorothiazide Combination ScieGen Pharmaceuticals Inc received FDA approval for a generic versi...
Baxter
FDA Approves EPINEPHRINE — Baxter Healthcare Corporation
# FDA Approves Baxter Healthcare's Intramuscular Epinephrine Formulation Baxter Healthcare Corporation received FDA approval for its intramuscular ep...
SAGENT
FDA Approves Unknown Drug — SAGENT
On March 26, 2026, SAGENT received FDA approval for a new drug, signaling a strategic entry into the market with potential to compete against existing...
Denali
FDA Approves AVLAYAH — Denali Therapeutics Inc.
# FDA Approves Denali Therapeutics' AVLAYAH, Expanding Its Neurology Portfolio Denali Therapeutics Inc. received FDA approval for AVLAYAH (tividenofu...
Macleods
FDA Approves MEXILETINE HYDROCHLORIDE — Macleods Pharmaceuticals Limited
# FDA Approves Generic Mexiletine Hydrochloride from Macleods Pharmaceuticals Macleods Pharmaceuticals Limited has received FDA approval for its gene...
Aurobindo
FDA Approves CEFIXIME — Aurobindo Pharma Limited
# FDA Approves Aurobindo Pharma's Generic Cefixime Oral Formulation The U.S. FDA has approved Aurobindo Pharma Limited's abbreviated new drug applica...
Advagen
FDA Approves ATOMOXETINE HYDROCHLORIDE — Advagen Pharma Ltd.
# FDA Approves Advagen Pharma's Atomoxetine Hydrochloride for Oral Administration Advagen Pharma Ltd. has received FDA approval for its atomoxetine h...
FRESENIUS
FDA Approves Unknown Drug — FRESENIUS KABI USA
# FDA Approves Generic Drug for Fresenius Kabi USA Fresenius Kabi USA received FDA approval for a generic drug formulation under ANDA219991, expandin...
ACTAVIS
FDA Approves Unknown Drug — ACTAVIS LABS FL INC
# FDA Approves Generic Drug Application for Actavis Labs FL Inc Actavis Labs FL Inc received FDA approval for abbreviated new drug application (ANDA)...
Septodont,
FDA Approves FLAVALTA — Septodont, Inc.
Septodont Inc. has received FDA approval for the Flavalta submucosal lidocaine and epinephrine system, a launch set for March 19, 2026, which is expec...