Easy access to this kind of test could help people determine what kind of precautions they should take against COVID-19 infection, such as getting an additional booster shot, the researchers said.
More than 200 million Pfizer doses have been administered in the US, and hundreds of millions more worldwide, since December.
Indian drug firms continue to work closely with the FDA, and most have also appointed consultants to help them grasp the regulatory minutiae in the US.
The emergency use of the drug will be for adult COVID-19 patients with SpO2 93 percent and who have a high risk of progression of the disease including hospitalisation or death subject to certain conditions
Baltimore-based Lupin Pharmaceuticals Inc is recalling 5,60,922 pouches of Mibelas 24 Fe (norethindrone acetate and Ethinyl estradiol tablets and ferrous fumarate tablets) in the US, as per the latest enforcement report by the USFDA.
The Drugs Controller General of India has approved the manufacture of this Sars-CoV-2 spike protein recombinant nano-particle vaccine for 'examination, test, and analysis', reports Sohini Das.
As marketing rights for off-patent drugs in the US become less exclusive, companies are scrambling for fresh strategies to make up for the revenue loss.
The move follows an FDA inspection of a Ranbaxy facility which identified significant violations of sound manufacturing practices.
In the final part of a three-part series on America's war on substandard Indian generic drugs, Aziz Haniffa speaks about American doctors' contempt for drugs exported from India and the ineptitude of the US Food and Drug Administration to stop the menace.
US drug regulator's fiat on Mohali factory, after strictures on the two other major Indian units, has numerous negative implications.
The company said the drug will be made available across India through the group's strong distribution chain reaching out to government and private hospitals treating COVID-19 patients.
This generic Doxorubicin HCl Liposome injection USP, 2 mg/ml is therapeutically equivalent to Doxil Liposome Injection, 2 mg/ml of Janssen Research and Development, LLC.
After recovering from issues such as defaults on foreign currency convertible bonds and piling debts, pharmaceutical major Wockhardt has been on the slow lane through the last six months, following warnings from global regulators such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare Products Regulatory Agency.
The number of dollar billionaires in India has risen to 55 this year from 46 last year.
An advocate on Wednesday approached the Supreme Court with a PIL seeking cancellation of the license granted to Ranbaxy Laboratories and for initiating probe against the pharma major for allegedly manufacturing and selling adulterated drugs.
.jpg)
As per the media report, the US Food and Drug Administration is learnt to have issued a Form 483 to the company's manufacturing facility at Mohali a few months ago after finding deviations from norms during an inspection of the plant.
Patient safety and quality our guidance now, says CEO and MD Arun Sawhney.
Many say trend could lead to concerns on manufacturing quality in Indian facilities.
The US FDA, during its inspection of Ranbaxy's manufacturing facilities in India, between 2006 and 2008, had found violations, incomplete testing records and an inadequate stability programme, besides manufacturing practices that did not follow regulations.
Wockhardt might be headed for another crisis, as it has come under the scanner of US health regulator.
Last week, Sun's Israeli subsidiary, Taro Pharma, received the US Food and Drug Administration's approval for its New Drug Application to launch Topicort Topical Spray for the treatment of psoriasis.
In the last one month, Indian pharmaceutical company Lupin has won US Food and Drug Administration nod for three of its contraceptive pills, and has at least nine approvals pending with the regulator.
The 2008 deal agreement contains provisions of arbitration to be held in that country.
Daiichi alleged that Singh brothers had concealed and misrepresented critical information concerning US Food and Drug Administration and Department of Justice investigations into Ranbaxy
Tech Mahindra and United Spirits will replace them in the 50-share index of the National Stock Exchange with effect from March 28.
Through a Freedom of Information Act request, the Show '20/20' obtained lists of recent health violation records from the FDA, the agency in charge of inspecting airlines and their outside food caterers.
A popular energy drink, produced by a company founded by an Indian-American billionaire, has come under the scanner in the United States after reports of 13 deaths possibly linked to the energy shots.
Work to begin after that on corrective measures to meet US regulator's requirements.
Regulator says fee would enable it to quicken approval process.
USFDA has extended the timeline for granting tentative approval to generic drug applications filed under Para IV of its rules by 10 months.
There are also lingering concerns over the culture of misuse of pharmaceutical products in India, which has, in the past, led to other drugs becoming increasingly ineffective.
Wockhardt said it is launching the product immediately in the US market.
Ranbaxy was scheduled to launch its drug on September 21, the day Diovan's patent expired.
In 2012, drugs worth $35 billion went off-patent in the US, while the market size of drugs which will see patent expiry in 2013 will halve to $17 billion.
Import alert on unit-6 facility might be lifted by FDA by Sept.
USFDA consent decree reveals that firm will have to forego huge short-term opportunities for its generics.
Ranbaxy has also agreed to relinquish any 180-day marketing exclusivity that it might have for three pending generic drug applications.
Pfizer Inc and its group companies filed a petition in a US court against Aurobindo Pharma Ltd and Dr Reddy's Laboratories alleging that the Indian drug-makers were planning separately to come out with generic versions of its blockbuster multi-billion dollar drug Ibrance (palbociclib) before expiration of its patent.
The regulator has given the company 15 days to take corrective measures and report back to it.
This move could cost $299 million a year for Indian pharma players.
© 2026 Rediff.com - Advertise with us - Disclaimer - Privacy Policy - Sitemap - Feedback - About us - Terms of use - Grievances