Latest news with #Zithromax
Yahoo
12-08-2025
- Health
- Yahoo
GSK's oral antibiotic for gonorrhoea set for FDA review
A new pill that combats antibiotic-resistant strains of gonorrhoea has inched closer to approval in the US, after the US Food and Drug Administration (FDA) accepted GSK's gepotidacin for priority review. A priority review expedites the FDA's decision on a drug application, cutting review time down from 10 to six months. The agency has set a Prescription Drug User Fee Act (PDUFA) action date of 11 December 2025. If approved, it would be indicated for the treatment of uncomplicated urogenital gonorrhoea in patients aged 12 years and older who weigh at least 45kg. Gepotidacin is already available in the US under the brand name Blujepa for the treatment of urinary tract infections (UTI) in women and girls aged 12 years and above, courtesy of an FDA approval in March 2025. Currently, gonorrhoea treatment options in the US mostly rely on injectable drugs, such as Roche's Rocephin (ceftriaxone). While there are oral antibiotics approved by the FDA, these are often broad-use drugs such as Pfizer's Zithromax (azithromycin). In a Phase III trial (NCT04010539) that enrolled than 600 adults and teenagers, gepotidacin was shown to successfully treat about 92% of patients when taken twice daily. This was non-inferior when compared with a standard combination therapy of Rocephin and Zithromax, which had success rates of 91.2%. There were also no failures at the urogenital site due to bacterial persistence arising from gonorrhoea, signifying gepotidacin's important role against resistant strains. Data from the World Health Organization (WHO) shows a rise in the prevalence of multi-resistant gonorrhoea. As of 2023, out of 87 countries where enhanced gonorrhoea antimicrobial resistance surveillance was conducted, nine countries reported elevated levels of resistance to Rocephin. Antibiotic-resistant strains of gonorrhoea mean tackling its spread is harder at public health levels. Developed by GSK but with funding from US infectious disease grants, Gepotidacin is a triazaacenaphthylene antibiotic that inhibits bacterial DNA replication. The drug inhibits two different Type II topoisomerase enzymes, which gives it activity against a range of pathogens that target the urinary system. Another oral antibiotic could also be set to join gepotidacin in the US drug armoury against gonorrhoea. In June, the FDA accepted a new drug application for zoliflodacin, co-developed by Innoviva Specialty Therapeutics and Global Antibiotic Research & Development Partnership (GARDP). Zoliflodacin's PDUFA date is assigned for 15 December 2025, four days later than that for gepotidacin. A major milestone in the gonorrhoea treatment space occurred in the UK last week when the NHS rolled out free vaccines for those at high risk of infection. The GSK-developed 4CMenB vaccine is approved to prevent meningococcal B, but a UK vaccine committee recommended its off-label use to curb rising cases. It marks the first time in the world that a vaccine is being used to combat gonorrhoea. "GSK's oral antibiotic for gonorrhoea set for FDA review" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Arabian Business
31-03-2025
- Health
- Arabian Business
Top Dubai real estate investments, developers and financing revealed; DIFC hedge fund seeks interns; Pfizer antibiotics update – 10 things you missed this week
Latest in antibiotic medicine EXCLUSIVE: Pfizer recalls bacteria-fighting antibiotic Zithromax from UAE market by Tala Michel Issa Wed 5 Mar 2025 Popular antibiotic that is used to fight STIs, skin and respiratory infections vanishes from pharmacy shelves as Pfizer works to resolve 'manufacturing' issue Video: Should the Covid-19 vaccine be patent-free? by ITP Mon 17 Aug 2020 The race is on for what some argue will be the most coveted resource of our time: a Covid-19 vaccine.
Arabian Business
05-03-2025
- Health
- Arabian Business
EXCLUSIVE: Pfizer recalls bacteria-fighting antibiotic Zithromax from UAE market
Pharmaceutical giant Pfizer has confirmed the recall of popular antibiotic Zithromax from UAE pharmacy shelves, citing 'a manufacturing-related matter' as the cause. 'Pfizer is recalling Zithromax 250mg capsules due to a manufacturing-related matter, which does not impact product quality or safety,' a Pfizer spokesperson told Arabian Business. 'Pfizer has determined the root cause and is working to implement appropriate corrective and preventive actions.' The company emphasised patient concerns are being addressed. 'We fully realise the importance of this medicine for patients and are working as quickly as possible to resolve the matter. Patients currently taking the product should consult with their healthcare provider about alternative treatment options.' The recall, which reportedly occurred approximately 2-3 weeks ago, has left pharmacies across the UAE without stock of the widely prescribed medication, according to multiple pharmacy sources contacted by Arabian Business. Zithromax, which contains azithromycin, is commonly prescribed to treat various bacterial infections, including respiratory infections, skin infections, ear infections, and sexually transmitted infections such as chlamydia. The medication is also used to prevent infections caused by Mycobacterium Avium-intracellulare Complex (MAC) in certain patients. Pharmacies confirm recall Arabian Business contacted several pharmacies across Dubai to confirm the recall. Staff at multiple locations verified that the medication had been pulled from shelves. 'The company took back all stock, it has not come back into the market yet. They didn't disclose the reason why. It was recalled 2-3 weeks ago,' said a pharmacist at MedX Pharmacy's Al Barsha branch. A representative at another MedX branch in Dubai provided further insight. 'It was recalled almost a month ago. I guess it was a bad batch. It hasn't caused much issues in the market as there are alternative brands of the same type of antibiotic available.' Similarly, a staff member at Aster Pharmacy's Pinnacle Tower branch confirmed, 'They recalled them a long time ago. We haven't been receiving anything. There are different brands of antibiotics people are using.' The medication works by stopping the growth of bacteria that cause infections and is not effective against viral infections such as the common cold or flu. Health authorities typically issue recalls of pharmaceutical products when issues related to safety, efficacy, or quality control are identified. These can range from manufacturing inconsistencies to contamination or labelling errors.
Yahoo
20-02-2025
- Health
- Yahoo
What we know about photo allegedly showing $300M worth of meds set to expire due to USAID cuts
In mid-February 2025, a photograph spread on social media purportedly showing $300 million worth of medication sitting in a warehouse and about to expire due to U.S. President Donald Trump's freeze on foreign aid spending. Sen. Chris Coons, D-Del., posted the image to X (archived) on Feb. 12, 2025, saying the drugs depicted would have prevented people "from going blind from a preventable tropical disease." He added, "Trump would rather waste them in an East African warehouse." His post also circulated on Threads and Facebook (archived, archived, archived). One X user who reposted the claim said it was an example of medicine nearing expiration "sitting in warehouses around the globe, unable to be used because of Trump's foreign aid halt" (archived). On Jan. 20, 2025, Trump announced an executive order that imposed a 90-day freeze on U.S. foreign aid programs. The administration also took an axe to the United States Agency for International Development (USAID), the main U.S. federal agency providing foreign aid. The Trump administration said it would put all directly hired employees of USAID on leave and recall thousands working overseas. However, on Jan. 29, Secretary of State Marco Rubio then issued a waiver of the 90-day pause, which allowed implementers of existing lifesaving humanitarian assistance programs to continue or resume their work. A spokesperson from Coons' office said via email that the medications depicted in the photograph were part of the USAID-funded Neglected Tropical Diseases (NTD) program, which Rubio's waiver did not exempt from the freeze. Coons is co-chair of the Senate Caucus on Malaria and NTDs. According to Coons' spokesperson, an individual affiliated with the NTD program took the photograph on Feb. 6 at a warehouse in Tanzania. The spokesperson said the individual wished to remain anonymous for fear of reprisal. The spokesperson also said most of the boxes visible in the photo contained the antibiotic Zithromax, which the pharmaceutical corporation Pfizer produced and donated to the program, and that the drugs could potentially go to waste. According to the spokesperson, "These drugs are at risk of expiration, as unless NTDs are added to the waiver, the program these medicines were donated for will not restart and there will be no way to get these medicines out of the warehouse." The spokesperson did not detail how many doses of Zithromax were in the boxes, nor the price per dose. Snopes contacted the drug's manufacturer, Pfizer, for comment. We will update this story if we receive a response. On Feb. 13, a federal judge in Washington, D.C., ordered a temporary thaw on Trump's foreign aid freeze. The ruling demanded the administration notify every organization with an existing contract with the federal government of the temporary stay. It also set a deadline of Feb. 18 for the government to inform the court of its compliance. However, some confusion remains over how funding will resume. We previously reported on the sequence of decisions that briefly froze the distribution of lifesaving HIV medication. "Bimmatrice (@Bimmatrice) on Threads." Threads, 12 Feb. 2022, Accessed 18 Feb. 2025. Blue, Craig. "$300 Million Worth of Medications Are Sitting on Pallets about to Expire Thanks to Trump's Effort to Gut Foreign Aid." 12 Feb. 2023, Accessed 18 Feb. 2025. Coons, Chris. "$300 Million Worth of Medications Are Sitting on Pallets about to Expire Thanks to Trump's Effort to Gut Foreign Aid." X (Formerly Twitter), 12 Feb. 2025, Accessed 18 Feb. 2025. "Emergency Humanitarian Waiver to Foreign Assistance Pause - United States Department of State." United States Department of State, 29 Jan. 2025, Accessed 18 Feb. 2025. Gharib, Malaka. "A Judge Orders a Temporary Thaw to Trump's Foreign Aid Freeze. What Will That Mean?" NPR, 14 Feb. 2025, Accessed 18 Feb. 2025. "Larry Evans (@Larrye2334) on Threads." Threads, 12 Feb. 2022, Accessed 18 Feb. 2025. "Reevaluating and Realigning United States Foreign Aid – the White House." The White House, 20 Jan. 2025, Accessed 18 Feb. 2025. "Trump Ordered to Temporarily Lift USAid Freeze and Allow Foreign Aid Funding." The Guardian, The Guardian, 14 Feb. 2025, Accessed 18 Feb. 2025. Wong, Edward. "Medicine with Expiration Dates Is Sitting in Warehouses around the Globe, Unable to Be Used because of Trump's Foreign Aid Halt." X (Formerly Twitter), 12 Feb. 2025, Accessed 18 Feb. 2025.
