Page 23 - Usfda

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

USFDA issues 13 observations after inspection of Lupin arm's facility in US

Drug firm Lupin said the US health regulator has issued 13 observations after inspection of its subsidiary's Somerset facility in New Jersey

Alembic Pharma gets tentative USFDA nod for breast cancer treatment drug

Drug firm Alembic Pharmaceuticals said it has received tentative approval from the US health regulator for Palbociclib capsules, used to treat a certain type of breast cancer

Cipla posts net profit of Rs 665 cr in Q2, income from ops grows 15%

The company's prescription biz grew 14% YoY supported by continued traction in the Covid portfolio

FDA panel reviews 1st new drug in 2 decades that claims to slow Alzheimer's

One of the biggest drug decisions in decades is looming as US regulators consider whether to approve the first medicine that's claimed to slow mental decline from Alzheimer's disease

USFDA approves Remdesivir as first Covid-19 therapy amid WHO reservations

Approval unlikely to increase prices immediately as Gilead has said licenses are royalty-free until the end of the health emergency

World Coronavirus Dispatch: US FDA approves remdesivir as first Covid drug

Philippines to allow foreign investors in, French curfew now covers two-thirds of its population, mouthwash won't shield you from virus, and other pandemic-related news across the globe

USFDA approves first coronavirus treatment drug - antiviral remdesivir

US regulators approved the first drug to treat COVID-19: remdesivir, an antiviral medicine given through an IV for patients needing hospitalization

Aurobindo Pharma gets USFDA nod for pain treatment injection Acetaminophen

Drug firm Aurobindo Pharma on Thursday said it has received final approval from the US health regulator for its generic Acetaminophen injection, used in the treatment of pain in adult and paediatric patients. The company has received the approval from the US Food & Drug Administration (USFDA) to manufacture and market Acetaminophen injection, 1,000 mg/ 100 mL single-dose vial, Aurobindo Pharma said in a BSE filing. The product will be launched in December 2020, it added. It is a generic version of Mallinckrodt's Ofirmev injection. According to IQVIA data, the approved product has an estimated market size of USD 339 million for the twelve months ending August 2020, Aurobindo Pharma said. Acetaminophen Injection is indicated for the treatment of mild to moderate pain in adult and paediatric patients 2 years and older. It is also set to treat moderate to severe pain with adjunctive opioid analgesics in adult and paediatric patients 2 years and older, and reduction of fever, the ...