Page 2 - Fda

Covid pill Paxlovid gets full FDA approval after a year of emergency use

Pfizer received full approval on Thursday for its COVID-19 pill Paxlovid that's been the go-to treatment against the coronavirus. More than 11 million prescriptions for Paxlovid have been dispensed since the Food and Drug Administration allowed emergency use in late 2021. The emergency status was based on early studies and was intended to be temporary pending follow-up research. The FDA granted full approval for adults with COVID-19 who face high risks of severe disease, which can lead to hospitalization or death. That group typically includes older adults and those with common medical conditions like diabetes, asthma and obesity. The decision allows Pfizer's drug to remain on the market indefinitely and to be marketed similarly to other drugs. The pill is still available for children ages 12 to 17 under a separate emergency authorisation. The US government has stockpiled millions of doses of Paxlovid and patients will continue to receive it at no charge, the FDA said in a stateme

FDA authorises combination flu-Covid test for home use to help consumers

The Food and Drug Administration on Friday approved the first combination test for flu and C OVID-19 that can be used at home, giving consumers an easy way to determine if a runny nose is caused by either disease. The Lucira COVID-19 & Flu Home test, which can be purchased without a prescription, uses self-collected nasal swab samples and delivers results in about 30 minutes, the agency said. While at-home COVID tests are readily available, this is the first home test for influenza A and B, commonly known as the flu. The test was granted an emergency use authorization, which facilitates the availability of medical countermeasures during public health emergencies. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, called the authorization a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home. The agency said the test is for individuals with signs and symptoms consistent with a respiratory tract ..

WHO stands by action of issuing alert against Maiden Pharma cough syrup

Asserts that testing done in labs in Ghana and Switzerland confirmed excess levels of contaminated syrups that are "dangerous and should not be in any medicine, ever"

'Patients cannot be forced to buy medicines from hospital-attached shops'

Patients cannot be compelled to purchase medicines from hospital-attached drug stores, the Maharashtra Food & Drug Administration (FDA) has said. A notification issued by Commissioner, FDA, Abhimanyu Kale said FDA had received repeated complaints that patients have been forced to buy medicines from the drug store in hospitals. "It is illegal for a hospital to force patients to buy medicines from their affiliated stores," said the notification, addressed to all the divisional joint commissioners, assistant commissioners, and drug inspectors (Drugs). Patients don't need to purchase medicines from hospital-affiliated shops and the same can be purchased from any licensed drug store, it said. The hospitals concerned should prominently display a signboard at a prominent place visible to the patients, as per the notification.

FDA takes action against 144 establishments since April in Maharashtra

A total of 175 establishments have been checked and action has been taken against 144 since April this year for various violations of rules and regulations, an official of the Konkan division of the Food and Drug Administration said on Friday. FDA Joint Commissioner Suresh Deshmukh said raids were conducted in Thane, Palghar, Raigad, Ratnagiri and Sindhudurg, which are part of the Konkan division. "Gutkha and tobacco products worth Rs. 2,92,01,518 were seized. At least 60 FIRs have been registered at various police stations. We have sealed 129 establishments and five vehicles have been confiscated," he said. "During 2021-22 a total of 105 establishments were inspected and action was taken against 99," he added.

Maha FDA asks drug controllers to stop Orofer FCM injection use

The Maharashtra Food & Drug Administration (FDA) has asked all drug controller authorities in the country to stop the use of a particular batch of drug INJ OROFER FCM following the death of a patient at a Mumbai hospital. A person died at Saifee Hospital in Mumbai due to suspected adverse drug reaction of the drug, said a senior official from FDA's Pune division on Wednesday. Orofer FCM injection is used to treat iron deficiency anaemia. Emcure Pharmaceuticals, the manufacturer, was asked to recall the particular batch of the drug, said S B Patil, Joint Commissioner (Drugs) FDA. The death of a person at Saifee Hospital was due to suspected adverse reaction of this drug, he said. As per the company, there could be spurious drugs available in the market in the name of INJ OROFER and because of such spurious drug the suspected adverse reaction might have taken place, he said. The company also told the FDA that spurious versions of one of its other drugs was already being sold ..

FDA approval for human consumption of lab-grown meat in the US

It's already possible to purchase some types of lab-grown meat in the world. Two years ago, Singapore became the first nation to approve the sale of cultivated meat

Cipla Q2 PAT up 11% PAT to Rs 789 cr on strong Covid-adjusted growth rate

The company is de-risking key product Abraxane in case the Goa plant FDA issue is not cleared immediately

Several states initiate action over contaminated cough syrup controversy

According to the media reports, Karnataka has directed all drugmakers to test samples of glycerine and propylene glycol and submit a report within seven days.

Drug regulator halts production at Maiden Pharma's Sonipat unit

Centre forms panel to analyse causal relation between deaths and cough syrups

Maharashtra FDA axe Johnson & Johnson's baby powder manufacturing license

Maharashtra's Food and Drugs Administration (FDA) on Friday cancelled the baby powder manufacturing licence of Johnson & Johnson Pvt Ltd "in the interest of public health at large". In a release, the state government agency said the company's product, Johnson's Baby Powder, may affect the skin of newborn babies. Samples of the powder for babies did not conform to standard pH value during a laboratory test, the regulator said. The release said the action was taken after Kolkata-based Central Drugs Laboratory's conclusive report that concludes "the sample does not conform to IS 5339:2004 with respect to the test for pH. According to the release, FDA had drawn samples of Johnson's Baby Powder from Pune and Nashik for quality check purposes. The government analyst had declared the samples as "not of the standard quality" as they do not comply with IS 5339:2004 specification for skin powder for infants in the test pH, it said. Thereafter, FDA issued a show-cause notice to ...

Maharashtra FDA cancels manufacturing licence of J&J baby powder

The state government body also said that the use of the product may affect the health of the skin of newborn babies

Top headlines: Vehicle sales up 8% in Aug; Fitch affirms rating for 4 NBFCs

Two-wheeler sales were up 8.5 per cent and three-wheeler by 8.3 per cent in August. Passenger and commercial vehicle sales increased 6.5 per cent and 24 per cent

FDA panel backs much-debated experimental ALS drug in rare second review

A panel of federal health advisers have voted to recommend approval for an experimental drug to treat Lou Gehrig's disease, a remarkable turnaround for the much-debated medication that was previously rejected by the same group earlier this year. The Food and Drug Administration advisers voted 7-2 that data from Amylyx Pharma warranted approval, despite hours of debate about the strength and reliability of the company's lone study. The FDA is not required to follow the group's advice, but its positive recommendation suggests an approval is likely later this month. The FDA has approved only two therapies for the disease, amyotrophic lateral sclerosis, or ALS, which destroys nerve cells needed for basic functions like walking, talking and swallowing. ALS patients and their families have rallied behind Amylyx's drug, launching an aggressive lobbying campaign and enlisting members of Congress to push the FDA to grant approval. Despite a negative review published by FDA's internal ...

USFDA rush after 2-year lull: 20-30% new products may be open to inspection

The last two years saw limited physical inspections due to travel restrictions during the pandemic

FDA authorizes first-ever breathing test for detecting Covid-19 infection

The agency said that in a study of 2,409 people, which included both people with and without symptoms, the test had a 99.3 per cent specificity rate

Moderna seeks FDA authorization for second Covid booster for all adults

Moderna Inc on late Thursday sought emergency use authorization with US health regulators for a second Covid booster shot, as a surge in cases in some parts of the world fuels fears of another wave

Moderna seeks FDA authorization for 4th dose of Covid vaccine shot

Drugmaker Moderna asked the Food and Drug Administration on Thursday to authorize a fourth shot of its COVID-19 vaccine as a booster dose for all adults. The request is broader than rival pharmaceutical company Pfizer's request earlier this week for the regulator to approve a booster shot for all seniors. In a press release, the company said its request for approval for all adults was made to provide flexibility to the Centers for Disease Control and Prevention and medical providers to determine the appropriate use of a second booster dose of the mRNA vaccine, including for those at higher risk of COVID-19 due to age or comorbidities." U.S. officials have been laying the groundwork to deliver additional booster doses to shore up the vaccines' protection against serious disease and death from COVID-19. The White House has been sounding the alarm that it needs Congress to urgently approve more funding for the federal government to secure more doses of the COVID-19 vaccines, either fo

US man who got first pig heart transplant dies after 2 months

David Bennett, 57, died Tuesday at the University of Maryland Medical Center

Covid: US FDA declines emergency use nod for Covaxin for 2-18 age group

Bharat Biotech's US partner Ocugen said it intends to continue working with the US FDA to evaluate the process for getting an EUA for pediatric use of Covaxin