Page 10 - Usfda

USFDA panel recommends emergency use authorisation of Moderna Covid vaccine

The US Food and Drug Administration's advisory panel, comprising external experts, has given an emergency use approval to Moderna Covid-19 vaccine

India Coronavirus Dispatch: 90 infections 'missed' for one detected

A slowing spread of the virus, measures to ensure safety in vaccine development, an expanding digital divide, and more-news relevant to India's fight against Covid-19

US regulators approve genetically modified pig for food, drugs use

US regulators have approved a genetically modified pig for food and medical products, making it the second such animal to get the green light for human consumption

US FDA confirms 94.1% efficacy of Moderna vaccine, says it's safe

Publishes findings ahead of key review, paving the way for a second vaccine

USFDA to scrutinise Pfizer's coronavirus vaccine data for red flags

Pfizer's Covid-19 vaccine faces one final hurdle as it races to become the first shot greenlighted in the US: a panel of experts who will scrutinise the company's data for any red flags

Aurobindo Pharma gets USFDA approval for drug used to sedate patients

Drug major Aurobindo Pharma said it has received final approval from the US health regulator for generic of Precedex injection, used for sedation of patients

UK ready for roll-out; Pfizer CEO not certain if shot stops spread

US, China also set to start process of inoculating their citizens from this week

Alembic Pharma gets USFDA nod for pills to treat salt, water retention

Alembic Pharmaceuticals said it received approval from the US health regulator for Metolazone tablets, indicated for the treatment of salt and water retention caused by heart failure or kidney disease

Glenmark Pharma gets tentative nod from USFDA for cancer treatment drug

Drug major Glenmark Pharma on Tuesday said it has received tentative approval from the US health regulator for Axitinib tablets, used in the treatment of kidney cancer. The tentatively approved product is the generic version of Inlyta tablets of PF Prism CV. Glenmark Pharmaceuticals Inc, USA has received tentative approval by the United States Food & Drug Administration (USFDA) for Axitinib tablets in the strength of 1 mg and 5 mg, the company said in a regulatory filing. Quoting IQVIA sales data for the 12 months ending October 2020, Glenmark Pharma said the Inlyta Tablets, 1 mg and 5 mg market achieved annual sales of approximately USD 518.8 million. Glenmark's current portfolio consists of 166 products authorised for distribution in the US market and 45 ANDA's pending approval with the USFDA.

India Coronavirus Dispatch: Situation remains grim in national capital

Covid may impact vision of some patients, ethical dilemma of denying vaccine to trial participants, UP artisans start selling online-news relevant to India's fight against the pandemic

Strides Pharma Science gets USFDA nod for generic Prednisone tablets

Strides Pharma Science Ltd on Monday said it has received approval from the US health regulator for its generic version of Prednisone tablets, prescribed for a variety of conditions, including allergies, respiratory illness and arthritis. The approval for Prednisone tablets by the US Food & Drug Administration (USFDA) granted to the company's step-down wholly owned subsidiary, Strides Pharma Global Pte Limited, Singapore, is for multiple strengths of 2.5 mg and 5 mg, Strides Pharma Science said in a regulatory filing. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Deltasone tablets, 2.5 mg and 5 mg, of Pharmacia and Upjohn Co, it added. Citing IQVIA MAT September 2020 data, the company said the US market for Prednisone Tablets USP, 2.5 mg and 5 mg is approximately USD 30 million. "The product will be manufactured at the company's flagship facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market," it ...

WHO advises doctors against using Gilead's remdesivir for treating Covid-19

The recommendation is a blow to Gilead's drug, which was one of the first thought to offer a meaningful benefit to coronavirus patients after a study showed it reduced their recovery time

USFDA approves first Covid-19 testing kit for home use; result in 30 mins

The US Food and Drug Administration said it had approved the first Covid-19 self-testing kit for home use that provides results within 30 minutes

Pfizer vaccine's -70 degree storage norm tough for most nations: V K Paul

Limited number of doses would not be enough to meet India's demand, adds Niti Aayog member

Aurobindo, Zydus, Jubilant, others recall various products in US market

Indian drug firms like Marksans Pharma, Aurobindo Pharma, Zydus and Jubilant are recalling products in the US market, as per the latest enforcement report by the USFDA

Aurobindo Pharma reports 26% increase in Q2 net profit at Rs 805 crore

The company said it received final approval for 10 ANDAs (abbreviated new drug applications) from USFDA

Glenmark Pharmaceuticals gets US FDA approval for Tacrolimus Capsules USP

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Tacrolimus Capsules USP, 0.5 mg, 1 mg and 5 mg, the generic version of Prograf®1 Capsules, 0.5 mg, 1 mg and 5 mg, of Astellas Pharm US, Inc.According to IQVIATM sales data for the 12 month period ending September 2020, the Prograf® Capsules, 0.5 mg, 1 mg and 5 mg market2 achieved annual sales of approximately USD 286.8 million*.Glenmark's current portfolio consists of 166 products authorized for distribution in the U.S. marketplace and 45 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.1 All brand names and trademarks are the property of their respective owners.2 Market includes brand and all available therapeutic equivalents* IQVIATM National Sales .

Eli Lilly's Covid-19 antibody drug treatment gets emergency USFDA clearance

The FDA authorised the experimental treatment, called bamlanivimab, for use against mild-to-moderate Covid-19 in adults, including those who are 65 and older, and pediatric patients

Pfizer coronavirus vaccine results leave questions about safety, longevity

The Pfizer trial started less than four months ago, and how long the vaccine will confer protection and how many will benefit are almost complete unknowns for now

Cost, timeline: Facts about Pfizer-BioNTech's '90% effective' Covid vaccine

The companies said the vaccine was more than 90% effective and they have so far found no serious safety concerns, priming it for possible speedy regulatory approvals