Page 9 - Usfda

Drug maker Caplin Steriles gets USFDA approval for an injection

The injection is used for short-term intravenous treatment of patients with acute decompensated heart failure

US weighs next steps for J&J virus shot amid clot mystery

U.S. health officials are weighing next steps as they investigate a handful of unusual blood clots in people who received Johnson&Johnson's COVID-19 vaccine a one-dose shot that many countries were eagerly awaiting to help speed virus protection. It's not clear if the exceedingly rare reports so far, six cases out of more than 7 million inoculations in the U.S. really are linked to the J&J vaccine. But the government recommended a pause in J&J vaccinations on Tuesday, just a week after European regulators declared that such clots are a rare but possible risk with the AstraZeneca vaccine, a shot made in a similar way but not yet approved for use in the U.S. The clots occurred in strange places, in veins that drain blood from the brain, and in people with abnormally low levels of clot-forming platelets. The six cases raised an alarm bell because that number is at least three times more than experts would have expected to see even of more typical brain-drainage clots, said

India fast-tracks emergency use of foreign-made Covid-19 vaccines

No need for prior local clinical trials for vaccines cleared by regulators

US calls for pause on J&J's Covid-19 vaccine after 6 clotting cases

The USFDA said one person had died from the rare blood clotting condition after taking the J&J vaccine and another was in a critical condition

USFDA authorises two changes to Moderna's vaccine against coronavirus

The US Food and Drug Administration has authorised two changes to Moderna's Covid-19 vaccine that can provide extra doses from each vial

Zydus Cadila receives tentative nod from USFDA to market two HIV drugs

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ Ahmedabad

This pharma stock has zoomed over 10,000% in 96 trading days

Orchid Pharma shares were locked in the upper circuit for the 96th straight trading day

Cipla receives USFDA nod for nasal spray for treating migraine attacks

Drug major Cipla on Tuesday said it has received final approval from the United States Food and Drug Administration (USFDA) for Sumatriptan Nasal Spray, indicated for the treatment of migraine attacks

FDA advisory panel to review J&J Covid-19 vaccine with thumbs up expected

(Reuters) - A panel of expert advisers to the U.S. Food and Drug Administration began a meeting to discuss Johnson & Johnson's one-dose COVID-19 vaccine on Friday, setting the stage for a possible emergency use authorization as early as this week.

FDA says single-dose shot from J&J vaccine prevents severe Covid-19

Johnson & Johnson's single-dose vaccine offers strong protection against severe COVID-19, according to an analysis released by US regulators that sets the stage for a final decision on a new and easier-to-use shot to help tame the pandemic. The long-anticipated shot could offer the nation a third vaccine option and help speed vaccinations by requiring just one dose instead of two. Food and Drug Administration scientists on Wednesday confirmed that overall the vaccine is about 66% effective at preventing moderate to severe COVID-19, and about 85% effective against the most serious illness. The agency also said J&J's shot is safe. The analysis is just one step in the FDA's evaluation. On Friday, the agency's independent advisers will debate if the evidence is strong enough to recommend the shot. With that advice, the FDA is expected to make a final decision within days. The COVID-19 death toll in the US topped 500,000 this week, and the vaccination drive has been slower than ...

Dr Reddy's launches stomach, esophagus problems treatment drug in US

The product is a therapeutic equivalent generic version of Prevacid SoluTab delayed release orally disintegrating tablets approved by the US Food and Drug Administration (USFDA)

Zydus Cadila gets USFDA final nod for low blood pressure drug Droxidopa

The newly approved medication will be manufactured at the group''s formulation manufacturing facility at SEZ, Ahmedabad

Weak US outlook in near term, higher costs to weigh on Torrent Pharma

While the stock has corrected, valuations leave little room for upside

Torrent Pharma Q3 net up by 18% to Rs 297 cr even as US revenues dip

India revenues grew 7% to stand at Rs 930 cr. Company's consolidated total revenue from operations fell marginally by under 1% to Rs 2,003 cr in Q3FY21

PE firm Advent International acquires 51% stake in ZCL Chemicals

ZCL is one of the fastest-growing manufacturers of specialty active pharmaceutical ingredients (APIs) and advanced intermediates

Alembic Pharma gets five observations from USFDA for Gujarat facility

Alembic Pharmaceuticals on Monday said the US health regulator has made five observations after inspection at its facility at Karkhadi, Gujarat. "The United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals' New Injectable Facility (F-3) located at Karkhadi from January 29-February 5, 2021. This was a scheduled inspection and at the end of the inspection, the USFDA issued a form 483 with 5 observations, the company said in a regulatory filing. As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. It notifies the company's management of objectionable conditions. Alembic Pharma said none of the observations were related to data integrity and were procedural in nature. "The company is preparing the response to the observations, which will be

Glenmark Pharma gets USFDA approval for nervous system stimulant drug

Glenmark Pharmaceuticals Ltd has been granted final approval by the United States Food and Drug Administration (USFDA) for Amphetamine Sulfate tablets USP

Strides Pharma Science arm gets USFDA nod for HIV treatment medicine

Strides Pharma Science said its step-down wholly-owned subsidiary, has received approval from the USFDA for Emtricitabine and Tenofovir Disoproxil Fumarate tablets, used to treat HIV

USFDA informs Biocon, Mylan of deferred action on biosimilar license plea

Biocon said its arm, Biocon Biologics, and Mylan have been informed by the USFDA of a deferred action on the biologics license application for a biosimilar to drug Avastin

Glenmark Pharma gets tentative nod from USFDA for blood thinning drug

Drug major Glenmark Pharma on Monday said it has received tentative approval from the US health regulator for anticoagulant Dabigatran Etexilate capsules