Antibiotic — Therapeutic Area Intelligence | Humanexa Signals

StrategyAugust 5, 2026

FDA Grants AP Status for Zydus' Linezolid ANDA206097

The FDA has granted Abbreviated Approval (AP) status for Zydus Pharmaceuticals' ANDA206097 for Linezolid.

RegulatoryJuly 29, 2026

FDA Approval Update for AUGMENTIN '875' Submission

The FDA has accepted a supplemental application for AUGMENTIN '875' from US ANTIBIOTICS.

RegulatoryJuly 28, 2026

FDA Accepts Supplement Application for METRO I.V. by B BRAUN

The FDA has accepted a supplemental application for METRO I.V. containing metronidazole from B BRAUN.

RegulatoryJuly 25, 2026

FDA Grants Approval for Dalbavancin Hydrochloride ANDA219604

The FDA has granted approval for the ANDA219604 application for Dalbavancin Hydrochloride submitted by BE PHARMS.

RegulatoryJuly 25, 2026

FDA Approves Augmentin '875' Supplement Application

The FDA has approved a supplemental application for Augmentin '875' submitted by US Antibiotics.

RegulatoryJuly 25, 2026

Watson Labs receives AP status for Ciprofloxacin Hydrochloride ANDA076794

Watson Labs has received an Abbreviated Approval (AP) for its ANDA076794 application for Ciprofloxacin Hydrochloride.

StrategyJuly 25, 2026

FDA Approval Update for Ciprofloxacin Hydrochloride by Hikma

Hikma has received an Abbreviated New Drug Application (ANDA) approval for Ciprofloxacin Hydrochloride.

RegulatoryJuly 24, 2026

Torrent's Moxifloxacin Hydrochloride ANDA Receives Approval Status

Torrent's ANDA for Moxifloxacin Hydrochloride has received an approval status (AP) from the FDA.

StrategyJuly 24, 2026

FDA Grants Approval for Doxycycline Hyclate ANDA210527 by Alembic

The FDA has granted approval for Alembic's Abbreviated New Drug Application for Doxycycline Hyclate.

RegulatoryJuly 23, 2026

FDA Accepts Supplemental Application for ZITHROMAX by Pfizer

The FDA has accepted a supplemental application for ZITHROMAX (azithromycin) from Pfizer.

StrategyJuly 23, 2026

Sagent Pharmaceuticals' Clindamycin Phosphate ANDA090108 Receives AP Status

Sagent Pharmaceuticals has received an Abbreviated New Drug Application (ANDA) approval status for Clindamycin Phosphate.

RegulatoryJuly 23, 2026

FDA Grants AP Status for Clindamycin Phosphate ANDA090109

The FDA has granted approval status (AP) for ANDA090109, a supplemental application for Clindamycin Phosphate by Sagent Pharmaceuticals.

RegulatoryJuly 23, 2026

FDA Accepts Supplemental NDA for Zithromax by Pfizer

The FDA has accepted a supplemental NDA for Zithromax (azithromycin) submitted by Pfizer.

RegulatoryJuly 21, 2026

FDA Grants Priority Review for ZAYNICH NDA Submission by Wockhardt Bio AG

The FDA has granted priority review for the NDA submission of ZAYNICH, containing cefepime hydrochloride and zidebactam.

RegulatoryJuly 21, 2026

FDA Grants AP Status for Clindamycin Phosphate Supplement by ALMAJECT

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for a supplement of Clindamycin Phosphate submitted by ALMAJECT.

RegulatoryJuly 21, 2026

FDA Grants AP Status for Clindamycin Phosphate Supplement by ALMAJECT

The FDA has granted approval status (AP) for the supplemental application ANDA062801 for Clindamycin Phosphate submitted by ALMAJECT.

RegulatoryJuly 21, 2026

FDA Grants AP Status for Clindamycin Phosphate Supplement by ALMAJECT

The FDA has granted an Abbreviated New Drug Application (ANDA) AP status for a supplement of Clindamycin Phosphate submitted by ALMAJECT.

RegulatoryJuly 20, 2026

FDA Grants AP Status for Doxycycline ANDA202778 by Strides Pharma

The FDA has granted Abbreviated Approval (AP) status for the Doxycycline ANDA202778 submitted by Strides Pharma.

RegulatoryJuly 20, 2026

FDA Approval Status Update for Cleocin (Clindamycin Palmitate Hydrochloride)

The FDA has updated the submission status for Cleocin, indicating an Abbreviated New Drug Application (ANDA) approval process.

RegulatoryJuly 19, 2026

FDA Accepts Supplement for Meropenem by ACS DOBFAR

The FDA has accepted a supplemental application for Meropenem submitted by ACS DOBFAR.

RegulatoryJuly 19, 2026

FDA Accepts Supplement Application for Clindamycin Phosphate by Encube

The FDA has accepted a supplemental application (ANDA212438) for Clindamycin Phosphate submitted by Encube.

StrategyJuly 16, 2026

FDA Grants Approval for Cefixime ANDA218691 by FDC LTD

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) 218691 for Cefixime submitted by FDC LTD.

RegulatoryJuly 16, 2026

FDA Approves Supplemental Application for Zithromax (Azithromycin)

The FDA has approved a supplemental application for Zithromax (Azithromycin) submitted by Pfizer.

RegulatoryJuly 16, 2026

FDA Approves Supplemental Application for Zithromax by Pfizer

The FDA has approved a supplemental application for Zithromax (azithromycin) submitted by Pfizer.

RegulatoryJuly 16, 2026

FDA Accepts Supplement for Zithromax (Azithromycin) by Pfizer

The FDA has accepted a supplemental application for Zithromax (azithromycin) from Pfizer.

RegulatoryJuly 16, 2026

FDA Approves Supplemental Application for Zithromax by Pfizer

The FDA has approved a supplemental application for Zithromax (Azithromycin) submitted by Pfizer.

RegulatoryJuly 16, 2026

FDA Accepts Supplement Application for NUZYRA (Omadacycline Tosylate)

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

RegulatoryJuly 15, 2026

FDA Grants AP Status for Watson Labs' Minocycline Hydrochloride

The FDA has granted approval status (AP) for Watson Labs' ANDA063181 for Minocycline Hydrochloride.

RegulatoryJuly 14, 2026

FDA Grants Priority Review for ZERBAXA Supplement by Cubist Pharmaceuticals

The FDA has granted priority review status for the supplemental NDA for ZERBAXA, which includes cefotolozane sulfate and tazobactam sodium.

RegulatoryJuly 10, 2026

Bristol Laboratories recalls Phenoxymethylpenicillin due to labeling issues

Bristol Laboratories Limited is recalling batch 7124002 of Phenoxymethylpenicillin 250 mg/5 ml Oral Solution due to labeling issues.

RegulatoryJuly 10, 2026

FDA Acceptance of Supplemental NDA for FETROJA by Shionogi

The FDA has accepted a supplemental NDA for FETROJA (cefiderocol sulfate tosylate) from Shionogi.

StrategyJuly 8, 2026

FDA Grants Approval for Novitium Pharma's Rifampin ANDA219918

The FDA has granted approval for Novitium Pharma's Abbreviated New Drug Application for Rifampin.

RegulatoryJuly 5, 2026

FDA Accepts Supplement for METRO I.V. in Plastic Container by B BRAUN

The FDA has accepted a supplemental application for METRO I.V., which contains metronidazole, by B BRAUN.

StrategyJuly 4, 2026

Impax Labs Receives AP Status for Tetracycline Hydrochloride ANDA060469

Impax Labs has received an Abbreviated Approval (AP) for their ANDA060469 submission for Tetracycline Hydrochloride.

RegulatoryJuly 3, 2026

FDA Accepts Supplement Application for ZEVTERA (Ceftobiprole Medocaril Sodium)

The FDA has accepted a supplemental application for ZEVTERA, indicating a potential expansion of its use.

RegulatoryJuly 2, 2026

Flamingo Pharma recalls Flucloxacillin Capsules due to incorrect patient information leaflet

Flamingo Pharma UK Ltd has recalled certain packs of Flucloxacillin Capsules BP 500mg due to containing the incorrect patient information leaflet for Amoxicillin.

RegulatoryJuly 1, 2026

FDA Accepts Supplemental Application for ZEVTERA (Ceftobiprole Medocaril Sodium)

The FDA has accepted a supplemental application for ZEVTERA, indicating potential new uses or indications.

RegulatoryJuly 1, 2026

FDA Accepts Supplement Application for ARIKAYCE Kit by Insmed

The FDA has accepted a supplemental application for the ARIKAYCE Kit, which contains amikacin sulfate.

RegulatoryJuly 1, 2026

FDA Approves Supplement for Bicillin L-A by King Pharmaceuticals

The FDA has granted approval for a supplemental application for Bicillin L-A, containing Penicillin G Benzathine.

RegulatoryJune 30, 2026

Brancaster Pharma Issues Class 4 Medicines Defect Notification for Benzylpenicillin

Brancaster Pharma Limited reported that certain batches of Benzylpenicillin benzathine were released with an outdated Patient Information Leaflet.

RegulatoryJune 23, 2026

FDA Grants Priority Review for UTEBZI (TEBIPENEM, PIVOXIL) by GlaxoSmithKline

The FDA has granted priority review status for NDA215960 for UTEBZI, an antibiotic containing TEBIPENEM and PIVOXIL.

RegulatoryJune 21, 2026

FDA Grants AP Status for Clindamycin Phosphate ANDA064050 by Padagis US

The FDA has granted abbreviated approval (AP) status for the ANDA064050 application for Clindamycin Phosphate submitted by Padagis US.

StrategyJune 21, 2026

Aurobindo Pharma's Cephalexin Receives FDA Approval

Aurobindo Pharma's ANDA213568 for Cephalexin has received FDA approval.

RegulatoryJune 21, 2026

FDA Approves Linezolid in Sodium Chloride 0.9% for Hospira

The FDA has approved Linezolid in Sodium Chloride 0.9% in a plastic container under NDA206473.

RegulatoryJune 21, 2026

FDA Approves Supplemental Applications for ZYVOX by Pfizer

The FDA has approved supplemental applications for ZYVOX (linezolid), indicating ongoing support for this antibiotic.

RegulatoryJune 21, 2026

FDA Approves Supplement for Vancomycin Hydrochloride in Plastic Container

The FDA has approved a supplemental application for Vancomycin Hydrochloride in a plastic container by Baxter Healthcare.

RegulatoryJune 19, 2026

FDA Approves First Oral Carbapenem for Complicated UTIs

The FDA has approved the first oral carbapenem therapy specifically for complicated urinary tract infections.

RegulatoryJune 18, 2026

Lupin's Doxycycline ANDA204234 Receives AP Status from FDA

Lupin's Abbreviated New Drug Application (ANDA204234) for Doxycycline has received an Approved Pending (AP) status from the FDA.

RegulatoryJune 7, 2026

FDA Grants AP Status for Doxycycline Hyclate Supplement by Impax Labs

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

Companies

Assets

Recent signals(49)

FDA Grants AP Status for Zydus' Linezolid ANDA206097

FDA Approval Update for AUGMENTIN '875' Submission

FDA Accepts Supplement Application for METRO I.V. by B BRAUN

FDA Grants Approval for Dalbavancin Hydrochloride ANDA219604

FDA Approves Augmentin '875' Supplement Application

Watson Labs receives AP status for Ciprofloxacin Hydrochloride ANDA076794

FDA Approval Update for Ciprofloxacin Hydrochloride by Hikma

Torrent's Moxifloxacin Hydrochloride ANDA Receives Approval Status

FDA Grants Approval for Doxycycline Hyclate ANDA210527 by Alembic

FDA Accepts Supplemental Application for ZITHROMAX by Pfizer

Sagent Pharmaceuticals' Clindamycin Phosphate ANDA090108 Receives AP Status

FDA Grants AP Status for Clindamycin Phosphate ANDA090109

FDA Accepts Supplemental NDA for Zithromax by Pfizer

FDA Grants Priority Review for ZAYNICH NDA Submission by Wockhardt Bio AG

FDA Grants AP Status for Clindamycin Phosphate Supplement by ALMAJECT

FDA Grants AP Status for Clindamycin Phosphate Supplement by ALMAJECT

FDA Grants AP Status for Clindamycin Phosphate Supplement by ALMAJECT

FDA Grants AP Status for Doxycycline ANDA202778 by Strides Pharma

FDA Approval Status Update for Cleocin (Clindamycin Palmitate Hydrochloride)

FDA Accepts Supplement for Meropenem by ACS DOBFAR

FDA Accepts Supplement Application for Clindamycin Phosphate by Encube

FDA Grants Approval for Cefixime ANDA218691 by FDC LTD

FDA Approves Supplemental Application for Zithromax (Azithromycin)

FDA Approves Supplemental Application for Zithromax by Pfizer

FDA Accepts Supplement for Zithromax (Azithromycin) by Pfizer

FDA Approves Supplemental Application for Zithromax by Pfizer

FDA Accepts Supplement Application for NUZYRA (Omadacycline Tosylate)

FDA Grants AP Status for Watson Labs' Minocycline Hydrochloride

FDA Grants Priority Review for ZERBAXA Supplement by Cubist Pharmaceuticals

Bristol Laboratories recalls Phenoxymethylpenicillin due to labeling issues

FDA Acceptance of Supplemental NDA for FETROJA by Shionogi

FDA Grants Approval for Novitium Pharma's Rifampin ANDA219918

FDA Accepts Supplement for METRO I.V. in Plastic Container by B BRAUN

Impax Labs Receives AP Status for Tetracycline Hydrochloride ANDA060469

FDA Accepts Supplement Application for ZEVTERA (Ceftobiprole Medocaril Sodium)

Flamingo Pharma recalls Flucloxacillin Capsules due to incorrect patient information leaflet

FDA Accepts Supplemental Application for ZEVTERA (Ceftobiprole Medocaril Sodium)

FDA Accepts Supplement Application for ARIKAYCE Kit by Insmed

FDA Approves Supplement for Bicillin L-A by King Pharmaceuticals

Brancaster Pharma Issues Class 4 Medicines Defect Notification for Benzylpenicillin

FDA Grants Priority Review for UTEBZI (TEBIPENEM, PIVOXIL) by GlaxoSmithKline

FDA Grants AP Status for Clindamycin Phosphate ANDA064050 by Padagis US

Aurobindo Pharma's Cephalexin Receives FDA Approval

FDA Approves Linezolid in Sodium Chloride 0.9% for Hospira

FDA Approves Supplemental Applications for ZYVOX by Pfizer

FDA Approves Supplement for Vancomycin Hydrochloride in Plastic Container

FDA Approves First Oral Carbapenem for Complicated UTIs

Lupin's Doxycycline ANDA204234 Receives AP Status from FDA

FDA Grants AP Status for Doxycycline Hyclate Supplement by Impax Labs

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