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The outbreak is particularly worrisome because the bacteria are resistant to standard antibiotics. CDC is further probing the presence of bacteria in unopened bottles of EzriCare eyedrops.

Quixplained: why US red-flagged India-made eyedrops

The outbreak is particularly worrisome because the bacteria are resistant to standard antibiotics. CDC is further probing the presence of bacteria in unopened bottles of EzriCare eyedrops.

Chennai-based Global Pharma Healthcare has suspended production of its eyedrops after US health regulator linked them to vision loss in the country.&nbsp;
US officials are investigating possible contamination in Ezricare Artificial Tears eyedrops which they say may have caused infections in the eye, blood, lungs and urine. Eye drops are used to treat irritation and dryness.
According to disease investigators, the infections were all caused by a bacteria called Pseudomonas aeruginosa. US officials have said the bacteria strain causing the infections is 'extensively resistant' to standard anti-biotics.&nbsp;
Investigators found the bacteria were not susceptible to any antibiotics routinely tested at public health laboratories. However, a newer antibiotic named cefiderocol did seem to work.
The US Centers for Disease Control and Prevention in a statement said that the bacteria was found in open bottles of Ezricare Artificial Tears and it is now probing the presence of bacteria in unopened bottles.&nbsp;
Also watch: <a href="https://www.editorji.com/india-news/india-made-eyedrops-recalled-after-55-infections-1-death-in-us-1675422285168">India-made eyedrops recalled after 55 infections, 1 death in US</a>
How could eye drops possibly infect the blood or lungs?
The eye connects to the nasal cavity through tear ducts and bacteria can move from the nasal cavity into the lungs. Also, bacteria in these parts of the body can seed infections at other sites such as in the blood or wounds, CDC officials said.
(with PTI inputs)

The US drug regulator gave full approval to Pfizer's Covid-19 vaccine on Monday for people 16 and older, making it the first to move beyond emergency use status.
This has made the two-shot Pfizer vaccine the first to receive full approval from the federal government.
“After a thorough, independent, and rigorous scientific review process that began more than a year ago, the FDA gave full approval to the Pfizer vaccine. Today’s announcement reaffirms the FDA’s findings that the vaccine is safe and effective,” the White House said.
Public health experts hope that this move will convince more unvaccinated Americans that Pfizer's shot is safe and effective.
The Pfizer vaccine has been in use in the US under an emergency authorisation since December 2020. Since then, more than 200 million Pfizer doses have been administered in the US.

US drug regulator gives full approval to Pfizer Covid-19 vaccine

The US drug regulator gave full approval to Pfizer's Covid-19 vaccine on Monday for people 16 and older, making it the first to move beyond emergency use status.

The US drug regulator gave full approval to Pfizer's Covid-19 vaccine on Monday for people 16 and older, making it the first to move beyond emergency use status.
This has made the two-shot Pfizer vaccine the first to receive full approval from the federal government.
&ldquo;After a thorough, independent, and rigorous scientific review process that began more than a year ago, the FDA gave full approval to the Pfizer vaccine. Today&rsquo;s announcement reaffirms the FDA&rsquo;s findings that the vaccine is safe and effective,&rdquo; the White House said.
Public health experts hope that this move will convince more unvaccinated Americans that Pfizer's shot is safe and effective.
The Pfizer vaccine has been in use in the US under an emergency authorisation since December 2020. Since then, more than 200 million Pfizer doses have been administered in the US.

The US drug regulator gave full approval to Pfizer's Covid-19 vaccine on Monday for people 16 and older, making it the first to move beyond emergency use status.
&nbsp;

The US drug regulator gave full approval to<a href="https://www.editorji.com/coronavirus/pfizer-vaccine-for-omicron-to-be-ready-in-march-for-approval-ceo-1641878458638" target="_blank"> Pfizer's Covid-19 vaccine</a> on Monday for people 16 and older, making it the first to move beyond emergency use status.
This has made the two-shot Pfizer vaccine the first to receive full approval from the federal government.
Also See |&nbsp;<a href="https://www.editorji.com/story/meet-zycov-d-the-world-s-first-dna-covid-19-vaccine-everything-you-need-to-know-about-the-new-vaccine-1629658709134" target="_blank">ZyCoV-D:&nbsp;The world&rsquo;s first DNA&nbsp;Covid-19&nbsp;vaccine; everything you need to know about the new vaccine</a>
&ldquo;After a thorough, independent, and rigorous scientific review process that began more than a year ago, the FDA gave full approval to the Pfizer vaccine. Today&rsquo;s announcement reaffirms the FDA&rsquo;s findings that the vaccine is safe and effective,&rdquo; the White House said.
Public health experts hope that this move will convince more unvaccinated Americans that Pfizer's shot is safe and effective.
The Pfizer vaccine has been in use in the US under an emergency authorisation since December 2020. Since then, more than 200 million Pfizer doses have been administered in the US.

Gujarat-based pharma giant Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market Fulvestrant injection, used in the treatment of breast cancer.
Zydus Cadila said this injection is either used alone or in combination with other drugs to treat certain types of advanced breast cancer cases.Zydus will now market the jab as 250 mg/5 mL or 50 mg/mL as a single-dose in pre-filled syringes.
The injection will be used in breast cancer cases where tumours are dependant on hormones such as estrogen to grow, or in cases where the breast cancer has spread to other parts of the body in women who are post-menopausal.
Also watch:&nbsp;Is it safe for breastfeeding mothers to take medicines like paracetamol and aspirin?
This injection will be manufactured at Zydus Cadila's formulation manufacturing facility at Zydus Biologics, Ahmedabad.

Zydus Cadila gets US FDA nod for Fulvestrant jab for breast cancer treatment

Zydus Cadila gets US FDA nod to market&nbsp;Fulvestrant injection for breast cancer treatment

//Zydus&nbsp;Cadila receives&nbsp;US FDA approval&nbsp;for breast&nbsp;cancer injection //Gujarat-based pharma&nbsp;company&nbsp;to market Fulvestrant injection //Injection is used alone or with other drugs to treat some cases //Zydus will market jab as 250 mg/5 mL or 50 mg/mL in a single-dose //Pharma&nbsp;giant&nbsp;to manufacture&nbsp;the pre-filled syringes in Ahmedabad

Zydus Cadila has received final approval from US Food and Drug Administration to market Fulvestrant Injection. This injection is used in the treatment of breast cancer.

Gujarat-based pharma giant Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market Fulvestrant injection, used in the treatment of breast cancer.
Zydus Cadila said this injection is either used alone or in combination with other drugs to treat certain types of advanced breast cancer cases. Zydus will now market the jab as 250 mg/5 mL or 50 mg/mL as a single-dose in pre-filled syringes.
The injection will be used in breast cancer cases where tumours are dependant on hormones such as estrogen to grow, or in cases where the breast cancer has spread to other parts of the body in women who are post-menopausal.
Also watch:&nbsp;<a href="https://www.editorji.com/story/is-it-safe-for-breastfeeding-mothers-to-take-medicines-like-paracetamol-and-aspirin-1626436894257" target="_blank">Is it safe for breastfeeding mothers to take medicines like paracetamol and aspirin?</a>
This injection will be manufactured at Zydus Cadila's formulation manufacturing facility at Zydus Biologics, Ahmedabad.

United States drug regulator has rejected the proposal for Covaxin&nbsp;to be used&nbsp;under emergency authorization.&nbsp;
Bharat&nbsp;Biotech's&nbsp;US arm Ocugen&nbsp;said that the&nbsp;FDA has asked the company to launch an additional trial so that it can file for for a full approval.Bharat Biotech&rsquo;s US partner stated, &ldquo;The FDA provided feedback and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data.&rdquo; BLA is Biologics Licence Application which is a full approval.
Ocugen however remains committed to the aim of bringing the home grown Indian vaccine to the US markets even as Bharat Biotech faces flak in India for not sharing data from its phase 3 clinical trials almost six months after the company&rsquo;s vaccine was included in the vaccination drive.&nbsp;

US FDA rejection hit for Bharat Biotech's Covaxin

US FDA rejection hit for Bharat Biotech's Covaxin, as the drug regulator asks for further trials.&nbsp;

United States drug regulator has rejected the proposal for Covaxin&nbsp;to be used&nbsp;under emergency authorization.&nbsp;
Bharat&nbsp;Biotech's&nbsp;US arm Ocugen&nbsp;said that the&nbsp;FDA has asked the company to launch an additional trial so that it can file for for a full approval.Bharat Biotech&rsquo;s US partner stated, &ldquo;The FDA provided feedback and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data.&rdquo; BLA is Biologics Licence Application which is a full approval.
Ocugen however remains committed to the aim of bringing the home grown Indian vaccine to the US markets even as Bharat Biotech faces flak in India for not sharing data from its phase 3 clinical trials almost six months after the company&rsquo;s vaccine was included in the vaccination drive.&nbsp;

us fda

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