A Milestone Moment: FDA Approves Addyi® for Hypoactive Sexual Desire Disorder in Postmenopausal Women
December 17, 2025
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Brand Name :
N/A
Synonyms :
cefepime and taniborbactam 63
Class :
Antibiotics/ beta-lactam/beta-lactamase inhibitor
Brand Name :
N/A
Synonyms :
cefepime and taniborbactam 63
Class :
Antibiotics/ beta-lactam/beta-lactamase inhibitor
Dosage Forms & Strengths
This drug is under pending for FDA approval for UTI and acute pyelonephritis
pending for FDA approval
pending for FDA approval
Actions and spectrum:
Cefepime binds to the penicillin-binding proteins and inhibits the synthesis of bacterial cell walls. Bacterial cell wall biosynthesis is essentially inhibited by this binding, which stops the last transpeptidation of peptidoglycan synthesis. Cefepime basically causes bacterial death by rupturing the bacterial cell wall’s structural integrity.
Taniborbactam, an inhibitor of bicyclic boronate β-lactamase (BLI), is formerly known as VNRX-5133.
It selectively targets and inhibits a wide range of enzymes, including metallo-β-lactamases (like VIM and NDM), OXA-48, and serine-β-lactamases (like KPC or GES). By preventing these enzymes from functioning, taniborbactam makes cefepime more effective against gram-negative bacteria that are resistant to several medications
Frequency not defined
Changes in mood
Inflammation
Bloody or watery diarrhea
Reactions at the site of injection
Sore tongue
White and thick vaginal discharge
Loss of appetite
Irregular heartbeat
Convulsions
Breathing difficulty
Muscle cramps
Tremor
Yellowing of skin or eyes
Dark urine
Fever and chills
Nose bleeds or bleeding gums
Black Box Warning
There is no safety evidence available.
Contraindication/Caution:
Cross-hypersensitivity
Neurotoxicity
Pregnancy Warnings:
Pregnancy category: N/A
Lactation:
Excretion of the drug in human breast milk is unknown
Pregnancy Categories:
Category A: Satisfactory and well-controlled studies show no evidence of risk to the fetus in the first trimester or in the later trimester.
Category B: No evidence of risk to fetus found in animal reproduction studies and there are not enough studies on pregnant women.
Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women.
Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits.
Category X: Drugs listed in this category clearly outweigh risks over benefits. These category drugs should be prohibited for pregnant women.
Category N: There is no data available for the drug under this category.
Pharmacology:
Cefepime-taniborbactum is a BL/BI (beta-lactam/beta-lactamase inhibitor). it is an investigational drug.
Pharmacodynamics:
When it comes to the microbiological intent-to-treat (microITT) population’s primary effectiveness endpoint of composite microbiologic and clinical success at the Test of Cure (TOC) visit (Day 19–23), cefepime-taniborbactam outperformed meropenem.
Pharmacokinetics:
Still under investigation.
Administration:
The combination drug cefepime and taniborbactam should be given intravenously or as advised by the physician.
Patient information leaflet
Generic Name: cefepime-taniborbactum
Why do we use cefepime-taniborbactum?
Cefepime-taniborbactum, an investigational drug, is being studied for its use in treating complicated urinary tract infections and pyelonephritis in adults. It is also effective against treating infections caused by CRE (carbapenem-resistant Enterobacterales), MDR-PA (multidrug-resistant- Pseudomonas aeruginosa), CRPA (carbapenem-resistant Pseudomonas aeruginous), and ESBL (extended-spectrum beta-lactamase) expressing Enterobacterales.
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