The company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for its medication in the strength of 400 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Doryx Tablets, 75 mg, 100 mg, 150 mg, and 200 mg, of Mayne Pharma International Pty Ltd (Mayne).
On Saturday afternoon, Sushma Hooda tweeted that she is requesting the prime minister "with great hope" to intervene and ensure early approval and purchase of the drug Trodelvy for the Indian market as it would grant her and several others a "lease of life".
The submission is based on results of Bharat Biotech's Phase 2/3 paediatric clinical trial involving 526 children between 2-18 years of age.
If the US Food and Drugs Administration (FDA) authorises the kid-size Covid-19 vaccination doses now, the Centers for Disease Control and Prevention will have to decide whether to recommend the shots and which youngsters should get them.
As per FDA scientists, Pfizer vaccine's benefit for preventing hospitalisations and death from Covid-19 would outweigh any serious potential side effects in children.
J&J told the Food and Drug Administration that an extra dose adds important protection as early as two months after initial vaccination — but that it might work better if people wait until six months later.
U.S. officials stress that the priority is to get shots to the 66 million unvaccinated Americans who are eligible for immunization -- those most at risk as the extra-contagious delta variant of the coronavirus has burned across the country.
Pfizer announced in a tweet that it had formally filed its application with the Food and Drug Administration.
People over 65 years of age, Young adults with underlying health conditions and people whose jobs put them at high Covid-19 infection risk to get booster doses. Food And Drug Administration(FDA) gives approval.
A key government advisory panel overwhelmingly rejected Biden's plan to give COVID-19 booster shots across the board and instead recommended the extra vaccine dose only for those who are age 65 or older or who run a high risk of severe disease.
Before this approval, this drug was only used for people who were confirmed with Covid-19 and were categorized as high-risk ones.
The company said that it would manufacture the drug at its manufacturing facility at the SEZ, Ahmedabad.
The top infectious disease expert in the U.S. says the Food and Drug Administration's decision Monday should encourage people who cited lack of approval as a reason for not getting vaccinated
The plan, as outlined by the director of the Centers for Disease Control and Prevention and other top authorities, calls for an extra dose eight months after people get their second shot of the Pfizer or Moderna vaccine.
The action is expected for the Pfizer shot in the coming weeks. However, the Food and Drug Administration is yet to formally approve the vaccine.
The announcement came on Thursday, by the Food and Drug Administration which applies to several million Americans who are especially vulnerable because of organ transplants, certain cancers, or other disorders.
Defense Secretary Lloyd Austin said the mid-September deadline could be accelerated if the vaccine receives final FDA approval or infection rates continue to rise.
A farmer sits near his red chillies at a deserted APMC market, during the weekend curfew imposed by the Karnataka government to curb the spread of COVID-19, in Hubballi.PTI Photo
Delhi Chief Minister & AAP National Convenor Arvind Kejriwal being welcomed by women supporters during his door-to-door campaign ahead of the Goa Assembly elections, in Goa.PTI Photo
A health worker collects swab sample of a woman for COVID-19 test, amid concerns over rising Omicron cases, in Gurugram.PTI Photo
Traffic jam on a road at Shalimar Bagh during the weekend curfew imposed by the Delhi government to curb the spread of Covid-19, in New Delhi.PTI Photo/ Shahbaz Khan
The Lajpat Nagar market wears a deserted look during the weekend curfew imposed by the Delhi government to curb the spread of Covid-19, in New Delhi.PTI Photo/ Shahbaz Khan
He would take his colour, brushes and canvas outside to paint and talk with his love. He would stand close to the window and paint, keeping an eye on his muse.
They say the violin mimics the human sound. In his case, it was that of love, of longing. He didn’t know any other way of loving.
Younger people do not have much progressive beliefs; a 2017 survey found that one-third of young people opposed inter-caste marriage.
The pandemic has made it clear that virtual learning is here to stay. In the West, the big question is whether it will dilute the quality of the college experience and education. In India, which grapples with digital divide, the question remains whether this will reach most people at all.
Even after two years of the Covid-19 pandemic, many 'informed' individuals in India continue to deny the virus with unscientific claims and unfounded data. The latest? Omicron will end the pandemic.
Across Asia there are deeply entrenched obstacles to a mode of higher education that is liberal in multiple senses – disciplinary and epistemological but also social and political.
The two incidents in the recent past, one in Mon district of Nagaland and the other at Lakhimpur Kheri in Uttar Pradesh, undermined the core principles democracy and federalism.