Remove Bacteria Remove Containment Remove FDA Approval
article thumbnail

FDA hits Ozempic and Mounjaro counterfeit compounders with warning letters

Pharmaceutical Technology

Some counterfeits contain bacteria and have high impurity levels or different chemical structures to Lilly's FDA-approved medicines.

Bacteria 239
article thumbnail

Likmez: First FDA-Approved Liquid Option of the Antibiotic Metronidazole

XTalks

Indicated for the treatment of trichomoniasis in adults, amebiasis in both adults and pediatric patients and anaerobic bacterial infections in adults, Likmez is available as an oral suspension, with each 5 mL containing 500 mg of metronidazole.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Boostrix Gains FDA Approval as Prenatal Immunization to Prevent Whooping Cough in Newborns

XTalks

Whooping cough , also known as pertussis, is a highly contagious respiratory infection caused by the Bordetella pertussis bacteria. The vaccine is a Tdap vaccine (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) that can be administered during the third trimester of pregnancy.

article thumbnail

Is the microbiome therapy hype up for a reckoning?

Pharmaceutical Technology

The idea behind these treatments relies on altering the gut microbiome by designing therapeutics that contain bacteria derived from donated stool samples. In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI.

Bacteria 278
article thumbnail

FDA Approves Rebyota as First Fecal Microbiome Therapy for Recurrent C. Difficile Infection

XTalks

According to the FDA, the infection causes about 500,000 illnesses and is associated with 15,000 to 30,000 deaths annually in the US. difficile as certain antibiotics can disrupt the balance of bacteria in the gut, allowing bacteria like C. Last year, the company partnered with Nestlé to market the drug once approved.

article thumbnail

Xdemvy Sets a New Standard in Demodex Blepharitis Care with FDA Nod

XTalks

Xdemvy, specifically formulated as an ectoparasiticide (anti-parasitic) for Demodex blepharitis treatment, contains the active ingredient lotilaner, a member of the isoxazoline compound family. How Does Xdemvy Work? This procedure, which takes just a few minutes, is crafted to address blepharitis and alleviate symptoms of dry eyes.

article thumbnail

BONESUPPORT CEO Emil Billbäck Shares Insights About Cerament G, the New Bone Void Filler Launching in the US

XTalks

BONESUPPORT received market authorization from the FDA for Cerament G, the first and only bone graft with antibiotic elution that is approved for the US market. Osteomyelitis is a bone infection caused by fungi or bacteria. What was special about this latest FDA approval from the company’s (BONESUPPORT’s) commercial perspective?

Filler 98