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Antibiotics

Mumbai-based Wockhardt to launch its novel antibiotic Zaynich by FY25-end

Global launch in FY26 after multinational clinical trial ends

Mumbai-based Wockhardt to launch its novel antibiotic Zaynich by FY25-end
Updated On : 28 Jun 2024 | 11:31 PM IST

Nepal's drug regulator bans sale of Indian antibiotic over quality issues

Zydus Lifesciences said the reports were 'misleading and erroneous'

Nepal's drug regulator bans sale of Indian antibiotic over quality issues
Updated On : 19 Jun 2024 | 9:27 PM IST

Nepal bars sale of Indian antibiotic injection Biotax 1gm over health risk

Nepal's Department of Drug Administration said laboratory tests on batch F300460 of 'Biotax 1gm', manufactured by Zydus Healthcare Ltd, indicated non-compliance with production standards

Nepal bars sale of Indian antibiotic injection Biotax 1gm over health risk
Updated On : 19 Jun 2024 | 2:16 PM IST

Lupin recalls 51k bottles of generic drug due to defective containers in US

Drug firm Lupin is recalling over 51,000 bottles of a generic antibiotic medication in the US market due to a "defective container", according to the American health regulator. The US-based arm of the drug maker is recalling 51,006 bottles of Cefdinir for Oral Suspension (250 mg/5 mL) due to "defective container: lack of seal integrity," US Food and Drug Administration (USFDA) said in its latest Enforcement Report. Cefrine Oral Suspension is indicated for the treatment of a range of bacterial infections. The affected lot has been manufactured at Lupin's Mandideep-based plant and marketed in the US by Baltimore-based Lupin Pharmaceuticals, Inc, it said. The drug maker initiated the Class II nationwide (US) voluntary recall on May 8 this year. As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health

Lupin recalls 51k bottles of generic drug due to defective containers in US
Updated On : 09 Jun 2024 | 11:21 AM IST

Experts flag need to stop OTC sale of antibiotics, spread awareness

The study adds that an estimated 7.7 million die in LMICs due to bacterial infections, of which almost five million deaths are due to AMR bacteria

Experts flag need to stop OTC sale of antibiotics, spread awareness
Updated On : 24 May 2024 | 9:19 PM IST

Justifying antibiotics prescription can help rationalise use: Experts

With the Union Health Ministry urging doctors to mandatorily mention indications and reasons for justification while prescribing antibiotics, infectious disease specialists say the initiative can help in rationalising antimicrobial usage and avoid indiscriminate consumption. The practice could also help further an evidence-based approach in medicine, along with improving patient outcomes, and curbing treatment costs and unwarranted side effects, they said. "Prescribers have to think and document the rationale before prescribing antimicrobials... This will help in the rational prescribing of antimicrobials and avoiding injudicious, indiscriminate usage," infectious disease specialist and senior consultant at the Yashoda Super Speciality Hospital in Kaushambi Dr Chhavi Gupta told PTI. In a letter to all doctors in medical colleges and medical associations on January 1, Director General of Health Services Dr Atul Goel urged them to make it a mandatory practice to write indications, ...

Justifying antibiotics prescription can help rationalise use: Experts
Updated On : 20 Jan 2024 | 11:26 AM IST

DGHS asks pharmacists to dispense antibiotics only on doctor's prescription

DGHS Atul Goel appealed to all pharmacists to strictly implement Schedules H and H1 of the Drugs and Cosmetics Rules, 1945, with regards to selling antibiotics

DGHS asks pharmacists to dispense antibiotics only on doctor's prescription
Updated On : 18 Jan 2024 | 9:07 PM IST

Govt urges doctors to mention justification while prescribing antibiotics

The Union Health Ministry has urged all doctors in medical colleges and medical associations to make it a mandatory practice to mention indication, reason for justification while prescribing antibiotics. Director General of Health Services Dr Atul Goel has also appealed to all pharmacists to strictly implement schedule H and H1 of the Drugs and Cosmetics Rules and stop over-the-counter sale of antibiotics and sell them only on the prescription of a qualified doctor. Misuse and overuse of antimicrobials are one of the main drivers in the development of drug-resistant pathogens, Goel said in a letter dated January 1. "With few new antibiotics in the research and development pipeline, prudent antibiotic use is the only option to delay the development of resistance," he stated. Antimicrobial resistance (AMR) is one of the top global public health threats facing humanity, the letter addressed to all doctors of medical colleges and to all medical associations said. It is estimated that

Govt urges doctors to mention justification while prescribing antibiotics
Updated On : 18 Jan 2024 | 8:36 PM IST

US health officials propose using cheap antibiotic as 'morning-after pill'

US health officials plan to endorse a common antibiotic as a morning-after pill that gay and bisexual men can use to try to avoid some increasingly common sexually transmitted diseases. The proposed CDC guideline was released Monday, and officials will move to finalise it after a 45-day public comment period. With STD rates rising to record levels, more tools are desperately needed, said Dr. Jonathan Mermin of the Centers for Disease Control and Prevention. The proposal comes after studies found some people who took the antibiotic doxycycline within three days of unprotected sex were far less likely to get chlamydia, syphilis, or gonorrhoea compared with people who did not take the pills after sex. The guideline is specific to the group that has been most studied gay and bisexual men and transgender women who had an STD in the previous 12 months and were at high risk of getting infected again. There's less evidence that the approach works for other people, including heterosexual m

US health officials propose using cheap antibiotic as 'morning-after pill'
Updated On : 03 Oct 2023 | 8:12 AM IST

Pharma major Lupin gets USFDA approval for its generic antibiotic

Pharma major Lupin Ltd on Monday said it has received approval from the US health regulator to market its generic antibiotic Doxycycline Hyclate delayed-release tablets used to treat bacterial infections. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Doxycycline Hyclate delayed-release tablets of strengths 50 mg, 60 mg, 75 mg, 80 mg, 100 mg, 120 mg, 150 mg, and 200 mg, Lupin said in a regulatory filing. This product will be manufactured at Lupin's Pithampur facility in India, it added. Doxycycline Hyclate Delayed-Release tablets had estimated annual sales of USD 9 million in the US, the company said citing IQVIA MAT June 2023 data.

Pharma major Lupin gets USFDA approval for its generic antibiotic
Updated On : 14 Aug 2023 | 8:40 PM IST

Wockhardt charting a recovery riding on a promising new antibiotic

While global trials are on, doctors have started using one of company's antibiotics against superbugs to save lives

Wockhardt charting a recovery riding on a promising new antibiotic
Updated On : 09 Jul 2023 | 2:18 PM IST

'Many newborns dying due to loss of efficacy of antibiotics against sepsis'

Many newborns are dying because the antibiotics used to treat sepsis are losing their effectiveness, according to a global observational study which involved over 3,200 newborn babies suffering from the infection in 11 countries, including India. The study, conducted from 2018 to 2020 and co-authored by a team of over 80 researchers, found there was high mortality among infants with culture-positive sepsis (almost 1 in 5 across the hospital sites), and a significant burden of antibiotic resistance. The research, published on Friday in the journal PLOS Medicine, provides a wealth of high-quality data aimed at improving the treatment of newborn babies with sepsis. "It was very important to undertake this study to get a better understanding of the kind of infections we are seeing in newborns in hospitals, the bugs causing them, the treatments that are being used and why we are seeing more deaths," said Manica Balasegaram, Executive Director of Global Antibiotic Research and Development

'Many newborns dying due to loss of efficacy of antibiotics against sepsis'
Updated On : 09 Jun 2023 | 5:03 PM IST

Pfizer suspends sale of three antibiotics in India over technical issues

Investigating matter with contract manufacturer Astral Steritech, says pharma firm

Pfizer suspends sale of three antibiotics in India over technical issues
Updated On : 18 May 2023 | 5:47 PM IST

Don't use antibiotics in Covid till bacterial infection suspected: Govt

Antibiotics should not be used in Covid cases unless there is clinical suspicion of bacterial infection, according to a revised guideline for the treatment of adult coronavirus patients issued by the Centre. The revised guidelines, issued on Sunday amid an uptick in coronavirus cases, stated that drugs such as Lopinavir-ritonavir, hydroxychloroquine, Ivermectin, Molnupiravir, Favipiravir, Azithromycin and Doxycycline should not be used for the treatment of adult COVID-19 patients in India. The AIIMS/ICMR-COVID-19 National Task Force met on January 5 to revise the clinical guidance protocol. It has also advised doctors not to use convalescent plasma therapy. "Antibiotics should not be used unless there is clinical suspicion of bacterial infection. Possibility of co-infection of COVID-19 with other endemic infections must be considered," the guidelines said. Additionally, in moderate or severe diseases at high risk of progression, Remdesivir may be considered for up to five days. It

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Updated On : 20 Mar 2023 | 4:45 PM IST

Glenmark Pharma receives USFDA approval for generic antibiotic drug

Glenmark Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic antibiotic drug. The company has received final approval from the US Food & Drug Administration (USFDA) for Clindamycin Hydrochloride Capsules, a generic version of Pfizer's Cleocin capsules, Glenmark Pharma said in a statement. Glenmark's Clindamycin Hydrochloride Capsules in strengths of 75 mg, 150 mg, and 300 mg, will be distributed in the US by Glenmark Pharmaceuticals Inc, it added. According to IQVIA sales data for the 12-month period ending January 2023, the Cleocin Hydrochloride Capsules, 75 mg, 150 mg, and 300 mg achieved annual sales of around USD 33.6 million. Glenmark shares were trading 0.12 per cent up at Rs 426.10 apiece on the BSE.

Glenmark Pharma receives USFDA approval for generic antibiotic drug
Updated On : 14 Mar 2023 | 2:19 PM IST

IMA advises against antibiotic use amid rising H3N2 flu cases in India

"Whenever there will be a real use of antibiotics, they will not work due to the resistance," the IMA wrote

IMA advises against antibiotic use amid rising H3N2 flu cases in India
Updated On : 04 Mar 2023 | 8:17 PM IST

Alkem launches novel antibiotic combination for drug-resistant infections

The formulation, to be sold under the Zidavi brans for Rs 2,700 a vial, has been approved by US FDA, European Medicines Agency, and CDSCO

Alkem launches novel antibiotic combination for drug-resistant infections
Updated On : 30 Jan 2023 | 6:24 PM IST

WHO concerned over increasing antibiotic resistance in human infections

Countries with lower rates of testing, mostly low- and middle-income countries, are more likely to report significantly higher AMR rates

WHO concerned over increasing antibiotic resistance in human infections
Updated On : 10 Dec 2022 | 10:42 AM IST

ICMR new guidelines warn against use of antibiotics for low-grade fever

The Indian Council of Medical Research has issued guidelines warning against the use of antibiotics for conditions such as low-grade fever and viral bronchitis while advising doctors to follow a timeline while prescribing them. The ICMR guidelines stated that antibiotics should be prescribed for a duration of five days for skin and soft tissue infections, five days in case of community-acquired pneumonia and eight days for hospital-acquired pneumonia. "A clinical diagnosis most often helps us predict causative pathogens fitting into a clinical syndrome which would tailor the correct antibiotic rather than blindly relying on fever, procalcitonin levels, WBC counts, cultures or radiology to make a diagnosis of infection," the guidelines said. It stated limiting empiric antibiotic therapy to seriously ill patients. Generally, empiric antibiotic therapy is only recommended for a select group of patients suffering from severe sepsis and septic shock, community-acquired pneumonia, ...

ICMR new guidelines warn against use of antibiotics for low-grade fever
Updated On : 27 Nov 2022 | 1:13 PM IST

Orchid Pharma antibiotic product for treating UTI coming to India: MD

Company says it's returning to profit after takeover by Dhanuka Laboratories under insolvency resolution

Orchid Pharma antibiotic product for treating UTI coming to India: MD
Updated On : 25 Nov 2022 | 12:12 AM IST