Cardiovascular — Therapeutic Area Intelligence | Humanexa Signals

RegulatoryAugust 6, 2026

FDA Submission Update for ALTACE (Ramipril) by King Pharmaceuticals

King Pharmaceuticals has submitted a supplemental application for ALTACE (Ramipril) with a standard review priority.

RegulatoryAugust 6, 2026

Teva's Losartan Potassium Supplement Application Receives Standard Review Status

Teva's ANDA for Losartan Potassium has been submitted and is currently under standard review by the FDA.

StrategyAugust 5, 2026

FDA Grants Approval for Atropine Sulfate ANDA219996

The FDA has granted approval for ANDA219996, a generic version of Atropine Sulfate, submitted by Gland.

StrategyAugust 5, 2026

Mankind Pharma's Rosuvastatin Calcium ANDA206603 Receives AP Status

Mankind Pharma's ANDA for Rosuvastatin Calcium has been granted Abbreviated Approval (AP) status by the FDA.

StrategyAugust 5, 2026

Aurobindo Pharma's Rosuvastatin Calcium Supplement Application Approved by FDA

The FDA has approved Aurobindo Pharma's supplemental application for Rosuvastatin Calcium.

StrategyAugust 5, 2026

Torrent's Rosuvastatin Calcium ANDA Receives Approval Status

Torrent's ANDA201619 for Rosuvastatin Calcium has received an approval status (AP) from the FDA.

RegulatoryAugust 5, 2026

FDA Accepts Supplement for Rosuvastatin Calcium by Alkem Labs

The FDA has accepted a supplemental application for Rosuvastatin Calcium from Alkem Labs.

RegulatoryAugust 5, 2026

FDA grants AP status for Atropine Sulfate ANDA218148 by Mankind Pharma

The FDA has granted approval status (AP) for the Abbreviated New Drug Application (ANDA) 218148 for Atropine Sulfate submitted by Mankind Pharma.

RegulatoryAugust 5, 2026

FDA Accepts Supplemental NDA for Brilinta (Ticagrelor) by AstraZeneca

The FDA has accepted a supplemental NDA for Brilinta (ticagrelor) submitted by AstraZeneca.

RegulatoryAugust 3, 2026

FDA Approves Torsemide Application ANDA217239 from Micro Labs

The FDA has approved the ANDA217239 application for Torsemide submitted by Micro Labs.

RegulatoryJuly 31, 2026

FDA Acceptance of Supplemental NDA for CRESTOR by AstraZeneca

The FDA has accepted a supplemental NDA for CRESTOR (rosuvastatin calcium) submitted by AstraZeneca.

RegulatoryJuly 31, 2026

FDA Approves Supplement for Atorvastatin Calcium by Sciegen Pharmaceuticals

The FDA has approved a supplemental application for atorvastatin calcium submitted by Sciegen Pharmaceuticals.

ClinicalJuly 30, 2026

Study Compares IV vs Oral Aspirin in Healthy Adults

A clinical trial is underway to evaluate the pharmacokinetics, pharmacodynamics, and safety of intravenous versus oral aspirin.

RegulatoryJuly 30, 2026

FDA Accepts Supplemental Application for AVAPRO by Sanofi

The FDA has accepted a supplemental application for AVAPRO (irbesartan) from Sanofi.

CompetitiveJuly 30, 2026

Study on Endografts for Aortic Aneurysms by Baptist Health and Collaborators

The study evaluates the Cook Zenith t-Branch and Terumo Arch Branch endografts for treating aortic aneurysms and proximal thoracic aortic pathologies.

RegulatoryJuly 29, 2026

FDA Approves Supplemental NDA for ZIAC by Teva

The FDA has approved a supplemental NDA for ZIAC, which contains bisoprolol fumarate and hydrochlorothiazide.

StrategyJuly 29, 2026

FDA Approves ANDA for Verapamil Hydrochloride by Knack

The FDA has approved the ANDA220076 for Verapamil Hydrochloride submitted by Knack.

RegulatoryJuly 29, 2026

FDA Accepts Supplement Application for Olmesartan Medoxomil and Hydrochlorothiazide

The FDA has accepted a supplemental application for the combination of Olmesartan Medoxomil and Hydrochlorothiazide submitted by Alkem Labs.

RegulatoryJuly 29, 2026

FDA Approval Status for Valsartan and Hydrochlorothiazide by Sciegen Pharms

The FDA has granted approval status (AP) for ANDA204687, a combination of Valsartan and Hydrochlorothiazide by Sciegen Pharms.

StrategyJuly 28, 2026

FDA Grants Approval for Valsartan ANDA218897 by Laurus

The FDA has granted approval for ANDA218897, a generic version of Valsartan, submitted by Laurus.

RegulatoryJuly 28, 2026

American Regent Issues Nationwide Recall of Papaverine Hydrochloride Injection Due to Contamination

American Regent, Inc. is recalling one lot of Papaverine Hydrochloride Injection due to contamination with glass particles.

RegulatoryJuly 27, 2026

FDA Grants AP Status for Colestipol Hydrochloride Supplement by Impax Labs

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for a supplement of Colestipol Hydrochloride submitted by Impax Labs.

RegulatoryJuly 26, 2026

FDA Approval Process for Olmesartan Medoxomil and Hydrochlorothiazide by Micro Labs

The FDA has received an application for Olmesartan Medoxomil and Hydrochlorothiazide from Micro Labs, currently under standard review.

ClinicalJuly 26, 2026

Daiichi Sankyo Trials Triple Therapy for Coronary Atherosclerosis Without Events

The trial evaluates a triple therapy of bempedoic acid, ezetimibe, and high-intensity statins on coronary plaque in patients without prior ischemic events.

RegulatoryJuly 24, 2026

FDA Accepts Supplement for Rosuvastatin Calcium by Macleods

The FDA has accepted a supplemental application for Rosuvastatin Calcium from Macleods Pharmaceuticals.

RegulatoryJuly 23, 2026

FDA Accepts Supplement for Rosuvastatin Calcium by Sun Pharma

The FDA has accepted a supplemental application for Rosuvastatin Calcium submitted by Sun Pharma.

StrategyJuly 23, 2026

FDA Accepts ANDA for Rosuvastatin Calcium by Sciegen Pharmaceuticals

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Rosuvastatin Calcium submitted by Sciegen Pharmaceuticals.

RegulatoryJuly 23, 2026

FDA Accepts Supplement for Diltiazem Hydrochloride by Novast Labs

The FDA has accepted a supplemental application for Diltiazem Hydrochloride submitted by Novast Labs.

RegulatoryJuly 23, 2026

FDA Accepts Supplemental Application for Argatroban by Fresenius Kabi

The FDA has accepted a supplemental application for Argatroban submitted by Fresenius Kabi.

CompetitiveJuly 23, 2026

Eli Lilly's Muvalaplin Trial Targets Cardiovascular Risk in High Lipoprotein(a) Patients

Eli Lilly is conducting a trial to assess muvalaplin's efficacy in reducing cardiovascular events in patients with elevated lipoprotein(a).

RegulatoryJuly 22, 2026

FDA Accepts Supplemental NDA for Argatroban in Dextrose by Sandoz

The FDA has accepted a supplemental NDA for Argatroban in Dextrose submitted by Sandoz.

RegulatoryJuly 22, 2026

FDA Accepts Supplement for Furosemide by Epic Pharma

The FDA has accepted a supplemental application for Furosemide submitted by Epic Pharma.

RegulatoryJuly 21, 2026

FDA Accepts Supplemental NDA for WIDAPLIK by Azurity

The FDA has accepted a supplemental NDA for WIDAPLIK, which includes amlodipine besylate, indapamide, and telmisartan.

ClinicalJuly 21, 2026

Registry Study for Minos™ Stent-Graft in Abdominal Aortic Aneurysm Treatment Launched

A post-market registry study has been initiated to evaluate the Minos™ Stent-Graft's safety and performance in real-world settings.

RegulatoryJuly 20, 2026

FDA Grants Approval for Losartan Potassium and Hydrochlorothiazide ANDA219869

The FDA has granted approval for ANDA219869, a combination of Losartan Potassium and Hydrochlorothiazide, submitted by Hetero Labs Ltd.

RegulatoryJuly 20, 2026

FDA Accepts Supplemental NDA for Argatroban by Accord Healthcare

The FDA has accepted a supplemental NDA for Argatroban in Sodium Chloride submitted by Accord Healthcare.

RegulatoryJuly 20, 2026

FDA mandates compliance for imported Heparin Sodium with USP specifications

The FDA is enforcing compliance for all imported Heparin Sodium to meet the latest USP specifications.

StrategyJuly 19, 2026

FDA Grants Approval for Nebivolol Hydrochloride ANDA212682

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) 212682 for Nebivolol Hydrochloride submitted by Prinston Inc.

RegulatoryJuly 19, 2026

FDA Grants AP Status for Verapamil Hydrochloride ANDA211035

The FDA has granted Abbreviated Approval (AP) status to Somerset for their ANDA211035 application for Verapamil Hydrochloride.

StrategyJuly 19, 2026

Breckenridge's Eplerenone ANDA208283 Receives Abbreviated Approval

Breckenridge's abbreviated new drug application for Eplerenone has received approval from the FDA.

RegulatoryJuly 19, 2026

FDA Accepts Supplemental NDA for Argatroban by Hikma Pharma

The FDA has accepted a supplemental NDA for Argatroban submitted by Hikma Pharma.

StrategyJuly 18, 2026

Abiomed recalls 14Fr Low Profile Introducer Kits due to thrombus risk

Abiomed has recalled its 14Fr Low Profile Introducer Kits due to the risk of thrombus formation with prolonged use.

RegulatoryJuly 18, 2026

FDA Accepts Supplement for Repatha (Evolocumab) by Amgen

The FDA has accepted a supplemental application for Repatha (evolocumab) from Amgen.

ClinicalJuly 18, 2026

AstraZeneca's AZD4954 Study Evaluates Safety and Pharmacokinetics in Healthy Adults

AstraZeneca is conducting a study to assess the safety, tolerability, PK, and PD of AZD4954 in healthy adults, including those with elevated Lp(a) levels.

RegulatoryJuly 18, 2026

Hospira's Heparin Sodium ANDA090571 Receives AP Status from FDA

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Heparin Sodium submitted by Hospira Inc.

StrategyJuly 18, 2026

FDA Grants Approval for Irbesartan ANDA077205 by Chartwell Molecular

The FDA has granted approval for ANDA077205, a supplemental application for Irbesartan submitted by Chartwell Molecular.

StrategyJuly 18, 2026

FDA Accepts ANDA for Choline Fenofibrate by Macleods Pharmaceuticals

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Choline Fenofibrate submitted by Macleods Pharmaceuticals.

RegulatoryJuly 18, 2026

FDA Grants Approval for Micro Labs' Choline Fenofibrate ANDA213450

The FDA has granted approval for Micro Labs' Abbreviated New Drug Application (ANDA) for Choline Fenofibrate.

RegulatoryJuly 18, 2026

FDA Grants AP Status for Heparin Sodium ANDA088100 from Hospira

The FDA has granted Abbreviated Approval (AP) status for Heparin Sodium under ANDA088100 submitted by Hospira.

StrategyJuly 18, 2026

FDA Grants AP Status for Hospira's Heparin Sodium Preservative Free

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Hospira's Heparin Sodium Preservative Free.

RegulatoryJuly 18, 2026

FDA Grants AP Status for Irbesartan ANDA206194 by Hisun Pharm

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Irbesartan submitted by Hisun Pharm.

ClinicalJuly 17, 2026

DETECT Study Aims to Identify Asymptomatic Atherosclerosis Prevalence and Risk Factors

The DETECT study aims to determine the prevalence of silent atherosclerosis in adults and identify risk factors for subclinical atherosclerosis.

ClinicalJuly 17, 2026

Study on Rivaroxaban's Effects in Peripheral Artery Disease Initiated

A clinical trial is underway to assess the impact of rivaroxaban on symptoms of peripheral artery disease.

RegulatoryJuly 16, 2026

FDA Approves Supplemental NDA for Argatroban by Fresenius Kabi

The FDA has approved a supplemental NDA for Argatroban submitted by Fresenius Kabi.

RegulatoryJuly 14, 2026

FDA Accepts Supplemental NDA for Amlodipine Besylate by Brillian Pharma

The FDA has accepted a supplemental NDA for Amlodipine Besylate submitted by Brillian Pharma.

RegulatoryJuly 13, 2026

Crescent Pharma recalls Ramipril 2.5mg due to packaging error

Crescent Pharma Limited is recalling Ramipril 2.5mg capsules due to a packaging error that may lead to patients receiving the incorrect dosage.

StrategyJuly 13, 2026

Crescent Pharma recalls Ramipril 2.5 mg Capsules due to packaging error

Crescent Pharma Limited is recalling a batch of Ramipril 2.5 mg Capsules due to a potential packaging error.

RegulatoryJuly 13, 2026

FDA Grants AP Status for Atropine Sulfate ANDA218148 by Mankind Pharma

The FDA has granted approval status (AP) for the Abbreviated New Drug Application (ANDA218148) for Atropine Sulfate submitted by Mankind Pharma.

RegulatoryJuly 12, 2026

FDA Approves ANDA203103 for Propranolol Hydrochloride by IPCA Labs

The FDA has approved ANDA203103 for Propranolol Hydrochloride submitted by IPCA Labs.

ClinicalJuly 12, 2026

Cleerly's CAD Staging System Trial Aims to Reduce Cardiovascular Events

A new trial is underway comparing Cleerly's CAD Staging System-based care to traditional risk factor-based care in preventing cardiovascular events.

RegulatoryJuly 12, 2026

FDA Grants Approval for Nitrogycerin ANDA214565 by Padagis Israel

The FDA has granted approval for the ANDA214565 application for Nitrogycerin submitted by Padagis Israel.

RegulatoryJuly 12, 2026

FDA Grants Approval for Torsemide ANDA217239 by Micro Labs

The FDA has granted approval for the ANDA217239 application for Torsemide submitted by Micro Labs.

CompetitiveJuly 11, 2026

Shape Memory Medical initiates pivotal trial for IMPEDE-FX in abdominal aortic aneurysm treatment

The AAA-SHAPE trial aims to evaluate the safety and effectiveness of IMPEDE-FX RapidFill in promoting aneurysm sac shrinkage post-EVAR.

RegulatoryJuly 10, 2026

FDA Approval Application for Rivaroxaban by Mankind Pharma

Mankind Pharma has submitted an application for Rivaroxaban under ANDA220874, currently under standard review.

ClinicalJuly 9, 2026

Procizumab shows safety and tolerability in first-in-human trial for cardiogenic shock

Procizumab (PCZ) demonstrated mild adverse events and no serious safety concerns in Phase 1 trial with healthy volunteers.

StrategyJuly 9, 2026

FDA Grants Approval for Chlorthalidone ANDA212229 by Macleods Pharmaceuticals

The FDA has granted approval for the ANDA212229 application for Chlorthalidone submitted by Macleods Pharmaceuticals.

StrategyJuly 9, 2026

FDA Grants Approval for Rivaroxaban Generic by Micro Labs

The FDA has granted approval for the generic version of Rivaroxaban submitted by Micro Labs.

RegulatoryJuly 8, 2026

FDA Submission Status Update for ABANTA (Apixaban) by AZURITY

The FDA has received a submission for ABANTA (Apixaban) under NDA221024 from AZURITY, currently under standard review.

RegulatoryJuly 8, 2026

FDA Approves Supplemental Application for CRESTOR (Rosuvastatin Calcium)

The FDA has approved a supplemental application for CRESTOR, a statin medication.

RegulatoryJuly 7, 2026

FDA Grants Approval for Atorvastatin Calcium Supplement

The FDA has granted approval for the atorvastatin calcium supplement submitted by Sciegen Pharmaceuticals.

ClinicalJuly 6, 2026

Study on Predictors of Major Adverse Limb Events After Iliac Stenting

A real-world cohort study will evaluate predictors of major adverse limb events after endovascular iliac artery stenting.

StrategyJuly 5, 2026

FDA Grants AP Status for Olmesartan Medoxomil and Hydrochlorothiazide ANDA207037

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Olmesartan Medoxomil and Hydrochlorothiazide submitted by Alkem Labs.

StrategyJuly 5, 2026

FDA Approves ANDA204687 for Valsartan and Hydrochlorothiazide

The FDA has approved ANDA204687, a generic formulation of Valsartan and Hydrochlorothiazide, submitted by Sciegen Pharmaceuticals.

ClinicalJuly 5, 2026

Study on Modified Antegrade Cerebral Perfusion in Aortic Dissection Surgery

The study evaluates the feasibility of modified antegrade cerebral perfusion (MACP) in emergency total arch replacement for acute type A aortic dissection.

StrategyJuly 5, 2026

FDA Grants Approval for Valsartan ANDA218897 by Laurus

The FDA has granted an Abbreviated New Drug Application (ANDA) approval for Valsartan submitted by Laurus.

ClinicalJuly 4, 2026

Study on Orbital Atherectomy for Critical Limb-Threatening Ischemia Launched in Europe

The ORACLE study will evaluate the effectiveness of orbital atherectomy in patients with critical limb-threatening ischemia across Europe.

RegulatoryJuly 4, 2026

FDA Grants Approval for Atropine Sulfate ANDA219013 by Edenbridge Pharmaceuticals

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) 219013 for Atropine Sulfate submitted by Edenbridge Pharmaceuticals.

RegulatoryJuly 3, 2026

FDA Accepts Supplemental Application for Argatroban by Teva Pharmaceuticals

The FDA has accepted a supplemental application for Argatroban in 0.9% sodium chloride submitted by Teva Pharmaceuticals.

ClinicalJuly 2, 2026

Trial Comparing Bypass Techniques in Thoracoabdominal Aneurysm Repair Initiated

A multicenter trial is underway to compare femorofemoral bypass and left-heart bypass techniques in TAAA repair.

RegulatoryJuly 1, 2026

Teva's Argatroban Supplement Receives FDA Acceptance

The FDA has accepted a supplemental application for Argatroban by Teva Pharmaceuticals.

ClinicalJuly 1, 2026

Phase III Trial of Digital Solutions in Cardiac Rehabilitation for ASCVD Patients

A Phase III trial is underway to evaluate the effectiveness of a digitally-enhanced rehabilitation package in ASCVD patients.

RegulatoryJune 30, 2026

FDA Accepts Supplemental Application for Eliquis (Apixaban)

The FDA has accepted a supplemental application for Eliquis, indicating ongoing development and potential label updates.

StrategyJune 30, 2026

Aurobindo Pharma's ANDA218949 for Icosapent Ethyl Receives AP Status

Aurobindo Pharma's ANDA218949 for Icosapent Ethyl has received an Abbreviated Approval (AP) status from the FDA.

RegulatoryJune 30, 2026

Hikma's Dipyidamole ANDA074521 Receives AP Status from FDA

Hikma's ANDA074521 for Dipyidamole has received an Abbreviated Approval (AP) status from the FDA.

StrategyJune 28, 2026

Crescent Pharma recalls Ramipril 10mg capsules due to manufacturing error

Crescent Pharma Limited is recalling a batch of Ramipril 10mg Capsules due to a potential manufacturing error.

RegulatoryJune 28, 2026

Sandoz Issues Class 4 Medicines Defect Notification for Apixaban Tablets

Sandoz Ltd. reported that the Patient Information Leaflet for certain batches of Apixaban tablets lacks up-to-date information.

RegulatoryJune 24, 2026

Crescent Pharma recalls Ramipril 5mg capsules due to manufacturing error

Crescent Pharma Limited is recalling a batch of Ramipril 5 mg Capsules due to a potential manufacturing error.

ClinicalJune 24, 2026

Regeneron initiates study of REGN13335 for Pulmonary Arterial Hypertension

Regeneron Pharmaceuticals is conducting a clinical trial to evaluate the safety and efficacy of REGN13335 in adults with Pulmonary Arterial Hypertension (PAH).

RegulatoryJune 23, 2026

Viatris Reports Quality Defect in Arixtra Pre-Filled Syringes

Viatris has identified a quality defect in Arixtra pre-filled syringes, with reports of brown discolouration and blockage due to needle oxidation.

RegulatoryJune 23, 2026

FDA Accepts Supplemental Application for Argatroban by Sandoz

The FDA has accepted a supplemental application for Argatroban submitted by Sandoz.

ClinicalJune 23, 2026

Phase 3 Trial of Dalcetrapib in ACS Patients with AA Genotype Initiated by DalCor Pharmaceuticals

DalCor Pharmaceuticals is initiating a phase 3 trial evaluating the effect of Dalcetrapib on cardiovascular risk in patients with recent acute coronary syndrome (ACS) and a specific genetic profile.

RegulatoryJune 22, 2026

FDA Accepts Supplement for Labetalol Hydrochloride by Epic Pharma

The FDA has accepted a supplemental application for Labetalol Hydrochloride submitted by Epic Pharma.

StrategyJune 21, 2026

FDA Grants Approval for Propranolol Hydrochloride ANDA219165

The FDA has granted approval for the ANDA219165 application for Propranolol Hydrochloride submitted by PAI Holdings.

RegulatoryJune 21, 2026

Cipla's NDA for Argatroban in Sodium Chloride Receives AP Status from FDA

Cipla's supplemental NDA for Argatroban in Sodium Chloride has been granted an Approval Pending (AP) status by the FDA.

ClinicalJune 21, 2026

Study on Low-Dose Antihypertensive Therapy in Prehypertensive Chinese Population

The study evaluates low-dose antihypertensive therapy's impact on new-onset hypertension and diabetes in high-normal blood pressure individuals.

RegulatoryJune 21, 2026

FDA Accepts Supplemental NDA for Argatroban in Sodium Chloride

The FDA has accepted a supplemental NDA for Argatroban in Sodium Chloride submitted by Eugia Pharma.

RegulatoryJune 21, 2026

FDA Grants AP Status for Losartan Potassium ANDA090382 by Strides Pharma

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Losartan Potassium submitted by Strides Pharma.

StrategyJune 21, 2026

Lupin's ANDA078232 for Losartan Potassium Receives AP Status from FDA

Lupin Ltd. has received an Abbreviated New Drug Application (ANDA) approval status for Losartan Potassium.

StrategyJune 21, 2026

Sandoz receives AP status for Irbesartan and Hydrochlorothiazide ANDA

Sandoz's ANDA077446 for Irbesartan and Hydrochlorothiazide has received an Abbreviated Approval (AP) status.

StrategyJune 20, 2026

Ezetimibe-atorvastatin SPC approved in China; economic value assessment needed

The single-pill combination of ezetimibe and atorvastatin was approved in China in 2023 and added to the NRDL in 2024.

StrategyJune 19, 2026

FDA Approves ANDA216272 for Norepinephrine Bitartrate by Nephron

The FDA has approved ANDA216272, a generic formulation of Norepinephrine Bitartrate, submitted by Nephron.

RegulatoryJune 19, 2026

Abiomed and Oscor Warn of Catheter Introducer Leakage Risk

Abiomed and Oscor reported a potential leakage issue in their introducer sheaths that may lead to increased access-site bleeding.

CompetitiveJune 16, 2026

Merck Publishes Method for Scalable Synthesis of Oral PCSK9 Inhibitor Enlicitide Decanoate

Merck has published a method for the large-scale synthesis of enlicitide decanoate, an investigational oral PCSK9 inhibitor.

ClinicalJune 16, 2026

Lilly's VERVE-102 Shows Significant LDL-C Reduction in Phase 1b Trial

VERVE-102 reduced PCSK9 levels by up to 88% and LDL-C by up to 62% in Phase 1b trial, with effects lasting up to 18 months.

StrategyJune 9, 2026

FDA Grants Approval for Olmesartan Medoxomil and Hydrochlorothiazide ANDA206371

The FDA has granted approval for ANDA206371, a combination of Olmesartan Medoxomil and Hydrochlorothiazide, submitted by Micro Labs.

RegulatoryJune 9, 2026

FDA Grants AP Status for Diltiazem Hydrochloride ANDA216327

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Diltiazem Hydrochloride submitted by Sciegen Pharmaceuticals.

RegulatoryJune 7, 2026

FDA Approval Status Update for Losartan Potassium by Micro Labs

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Losartan Potassium submitted by Micro Labs.

RegulatoryJune 6, 2026

FDA Grants Approval for Phenylephrine Hydrochloride by Baxter Healthcare

The FDA has granted approval for ANDA217032, a new application for Phenylephrine Hydrochloride submitted by Baxter Healthcare.

Companies

Assets

Recent signals(108)

FDA Submission Update for ALTACE (Ramipril) by King Pharmaceuticals

Teva's Losartan Potassium Supplement Application Receives Standard Review Status

FDA Grants Approval for Atropine Sulfate ANDA219996

Mankind Pharma's Rosuvastatin Calcium ANDA206603 Receives AP Status

Aurobindo Pharma's Rosuvastatin Calcium Supplement Application Approved by FDA

Torrent's Rosuvastatin Calcium ANDA Receives Approval Status

FDA Accepts Supplement for Rosuvastatin Calcium by Alkem Labs

FDA grants AP status for Atropine Sulfate ANDA218148 by Mankind Pharma

FDA Accepts Supplemental NDA for Brilinta (Ticagrelor) by AstraZeneca

FDA Approves Torsemide Application ANDA217239 from Micro Labs

FDA Acceptance of Supplemental NDA for CRESTOR by AstraZeneca

FDA Approves Supplement for Atorvastatin Calcium by Sciegen Pharmaceuticals

Study Compares IV vs Oral Aspirin in Healthy Adults

FDA Accepts Supplemental Application for AVAPRO by Sanofi

Study on Endografts for Aortic Aneurysms by Baptist Health and Collaborators

FDA Approves Supplemental NDA for ZIAC by Teva

FDA Approves ANDA for Verapamil Hydrochloride by Knack

FDA Accepts Supplement Application for Olmesartan Medoxomil and Hydrochlorothiazide

FDA Approval Status for Valsartan and Hydrochlorothiazide by Sciegen Pharms

FDA Grants Approval for Valsartan ANDA218897 by Laurus

American Regent Issues Nationwide Recall of Papaverine Hydrochloride Injection Due to Contamination

FDA Grants AP Status for Colestipol Hydrochloride Supplement by Impax Labs

FDA Approval Process for Olmesartan Medoxomil and Hydrochlorothiazide by Micro Labs

Daiichi Sankyo Trials Triple Therapy for Coronary Atherosclerosis Without Events

FDA Accepts Supplement for Rosuvastatin Calcium by Macleods

FDA Accepts Supplement for Rosuvastatin Calcium by Sun Pharma

FDA Accepts ANDA for Rosuvastatin Calcium by Sciegen Pharmaceuticals

FDA Accepts Supplement for Diltiazem Hydrochloride by Novast Labs

FDA Accepts Supplemental Application for Argatroban by Fresenius Kabi

Eli Lilly's Muvalaplin Trial Targets Cardiovascular Risk in High Lipoprotein(a) Patients

FDA Accepts Supplemental NDA for Argatroban in Dextrose by Sandoz

FDA Accepts Supplement for Furosemide by Epic Pharma

FDA Accepts Supplemental NDA for WIDAPLIK by Azurity

Registry Study for Minos™ Stent-Graft in Abdominal Aortic Aneurysm Treatment Launched

FDA Grants Approval for Losartan Potassium and Hydrochlorothiazide ANDA219869

FDA Accepts Supplemental NDA for Argatroban by Accord Healthcare

FDA mandates compliance for imported Heparin Sodium with USP specifications

FDA Grants Approval for Nebivolol Hydrochloride ANDA212682

FDA Grants AP Status for Verapamil Hydrochloride ANDA211035

Breckenridge's Eplerenone ANDA208283 Receives Abbreviated Approval

FDA Accepts Supplemental NDA for Argatroban by Hikma Pharma

Abiomed recalls 14Fr Low Profile Introducer Kits due to thrombus risk

FDA Accepts Supplement for Repatha (Evolocumab) by Amgen

AstraZeneca's AZD4954 Study Evaluates Safety and Pharmacokinetics in Healthy Adults

Hospira's Heparin Sodium ANDA090571 Receives AP Status from FDA

FDA Grants Approval for Irbesartan ANDA077205 by Chartwell Molecular

FDA Accepts ANDA for Choline Fenofibrate by Macleods Pharmaceuticals

FDA Grants Approval for Micro Labs' Choline Fenofibrate ANDA213450

FDA Grants AP Status for Heparin Sodium ANDA088100 from Hospira

FDA Grants AP Status for Hospira's Heparin Sodium Preservative Free

FDA Grants AP Status for Irbesartan ANDA206194 by Hisun Pharm

DETECT Study Aims to Identify Asymptomatic Atherosclerosis Prevalence and Risk Factors

Study on Rivaroxaban's Effects in Peripheral Artery Disease Initiated

FDA Approves Supplemental NDA for Argatroban by Fresenius Kabi

FDA Accepts Supplemental NDA for Amlodipine Besylate by Brillian Pharma

Crescent Pharma recalls Ramipril 2.5mg due to packaging error

Crescent Pharma recalls Ramipril 2.5 mg Capsules due to packaging error

FDA Grants AP Status for Atropine Sulfate ANDA218148 by Mankind Pharma

FDA Approves ANDA203103 for Propranolol Hydrochloride by IPCA Labs

Cleerly's CAD Staging System Trial Aims to Reduce Cardiovascular Events

FDA Grants Approval for Nitrogycerin ANDA214565 by Padagis Israel

FDA Grants Approval for Torsemide ANDA217239 by Micro Labs

Shape Memory Medical initiates pivotal trial for IMPEDE-FX in abdominal aortic aneurysm treatment

FDA Approval Application for Rivaroxaban by Mankind Pharma

Procizumab shows safety and tolerability in first-in-human trial for cardiogenic shock

FDA Grants Approval for Chlorthalidone ANDA212229 by Macleods Pharmaceuticals

FDA Grants Approval for Rivaroxaban Generic by Micro Labs

FDA Submission Status Update for ABANTA (Apixaban) by AZURITY

FDA Approves Supplemental Application for CRESTOR (Rosuvastatin Calcium)

FDA Grants Approval for Atorvastatin Calcium Supplement

Study on Predictors of Major Adverse Limb Events After Iliac Stenting

FDA Grants AP Status for Olmesartan Medoxomil and Hydrochlorothiazide ANDA207037

FDA Approves ANDA204687 for Valsartan and Hydrochlorothiazide

Study on Modified Antegrade Cerebral Perfusion in Aortic Dissection Surgery

FDA Grants Approval for Valsartan ANDA218897 by Laurus

Study on Orbital Atherectomy for Critical Limb-Threatening Ischemia Launched in Europe

FDA Grants Approval for Atropine Sulfate ANDA219013 by Edenbridge Pharmaceuticals