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Hydroxychloroquine is taken under schedule H1 of Drugs and Cosmetics rules by central government to prevent misuse and regulate sales of hydroxychloroquine. Hydroxychloroquine is anti-malarial medicine and known to have certain effects on novel corona virus infection (COVID-19) as per clinical trials.
The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic. Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed.
EMA has implemented a new system to issue electronic certificates for human and veterinary medicines. As of today, the Agency will no longer provide printed certificates but only electronically signed and authenticated certificates to maintain EMA’s ability to provide these documents during the COVID-19 pandemic.
Supporting the rapid development and approval of effective and safe treatments for and vaccines against COVID-19 is EMA’s top priority to help save lives during the pandemic. Over recent weeks and months, the Agency has engaged with many developers of therapeutic medicines and there are a number of developments underway. However, at this point, on the basis of the preliminary data presented to the Agency, no medicine has yet demonstrated efficacy in treating COVID-19.
Dr. Reddy’s Laboratories Ltd. (along with its subsidiaries together referred to as “Dr. Reddy’s”) announced today that it is voluntarily recalling four lots (ACB902, ACB903, ACB904, ACB905) of Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules to the hospital level. The product is being recalled due to product complaints received due to ampules breaking and shattering, upon opening, during compounding.
To combat Covid-19 pandemic, the World Health Organisation (WHO) insists that widescale “testing, testing, and testing” is the key as early diagnosis may help save lives. Aligning with the call of WHO, the Centre for Cellular and Molecular Biology (CCMB) is working overtime on the development of cost-effective and accurate diagnostic kits for wide distribution.
EMA is aware of recent media reports and publications which question whether some medicines, for instance angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs, or sartan medicines), could worsen coronavirus disease (COVID-19). ACE inhibitors and ARBs are most commonly used for treating patients with high blood pressure, heart failure or kidney disease.
EMA has recommended that fosfomycin medicines given by infusion (drip) into a vein should only be used to treat serious infections when other antibiotic treatments are not suitable. Fosfomycin medicines given by mouth can continue to be used to treat uncomplicated bladder infections in women and adolescent girls. They can also be used to prevent infection in men who undergo a procedure whereby a tissue sample is taken from their prostate (biopsy).
EMA’s safety committee (PRAC) recommended that medicines with daily doses of 10 mg or more of cyproterone should only be used for androgen-dependent conditions such as hirsutism (excessive hair growth), alopecia (hair loss), acne and seborrhoea (excessively oily skin) once other treatment options, including treatment with lower doses, have failed. Once higher doses have started working, the dose should be gradually reduced to the lowest effective dose.
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