US FDA

What is USFDA's Form 483?

The US carries out regular inspections at offshore drug making units to ensure quality compliance. In a recent check, the US FDA has issued Form 483 to Sun Pharma Halol unit. Let's demystify Form 483

"We're extremely pleased that we can proceed with our clinical trials for Covaxin our whole virus inactivated COVID-19 vaccine candidate," Dr Shankar Musunuri, CEO and Co-Founder, Ocugen Inc said

The US FDA has granted emergency use authorisation for a booster dose of the Pfizer-BioNTech vaccine for children aged between 5-11 years at least 5 months after completion of primary vaccine series

The product, which is indicated for the treatment of multiple myeloma (cancer of plasma cells) and mantle cell lymphoma (cancer of lymph nodes), is being launched immediately

Veklury is approved for young children who are hospitalised, or have mild-to-moderate Covid-19 and are at high risk for progression to severe Covid-19, according to the FDA

The US Food and Drug Administration has approved a fifth Covid-19 booster shot of Pfizer-BioNTech or the Moderna for people aged over 50 and some immunocompromised individuals.

US drug maker Moderna said it will request the Food and Drug Administration (FDA) to grant emergency use authorization for its Covid-19 vaccine to inoculate children under 6 years of age.

Pharmaceuticals firm Indoco Remedies Ltd on Tuesday said it has received final approval from the US health regulator for its generic Lacosamide tablet indicated for prevention and control of seizures.

Moderna submitted a request to the US Food and Drug Administration (FDA) for emergency use authorization on a fourth dose of its COVID-19 vaccine for adults 18 years of age and older

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.

In a statement on Monday, Bharat Biotech and its US partner Ocugen expressed their commitment towards bringing Covaxin to the US and Canada for all 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

Drug maker Lupin on Tuesday said it has launched Sevelamer Hydrochloride tablets (800 mg), used to treat hyperphosphatemia in patients with chronic kidney disease, in the US market

Glenmark Pharmaceuticals Limited said its subsidiary Glenmark Specialty S.A. has received US FDA approval for nasal spray fixed dose prescription drug for seasonal allergic rhinitis Ryaltris.

The FDA approved the drug in June despite its committee of outside experts voting in November 2020 that the drug should not be approved.

The drug, to be available under the brand name Quviviq, was approved in doses of 25 mg and 50 mg based on data from two late-stage trials

The group now has 325 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04, it added

The Food and Drug Administration in the US has said that rapid antigen tests are less sensitive for detecting Omicron variant infections

The US Food and Drug Administration (FDA) on Wednesday (local time) authorized Pfizer's Paxlovid COVID-19 pill for high-risk people aged 12 and over to treat coronavirus disease (COVID-19).

The Food and Drug Administration is loosening some restrictions on where women can obtain abortion pills, including a long-standing requirement that the medication be picked up in person