Us Food And Drug Administration

Stocks On Radar: HFCL, Waaree Energies, IREDA, Orchid Pharma in focus on 20 February

Join us for the latest stock market update where we cover the key stocks making headlines today. HFCL leads with a groundbreaking agreement under BharatNet Phase-III, while Waaree Energies secures a major solar module supply order. Plus, insights on IREDA and Tata Technologies' new trading contracts, Cyient's executive appointment, Patanjali Foods' legal victory, and Orchid Pharma's recent FDA inspection. Stay informed with our comprehensive overview of today's trading focuses!

Sun Pharma, Lupin recall drugs in US market: USFDA

Sun Pharma and Lupin recall US products due to manufacturing issues, says the US Food and Drug Administration (USFDA).

Zydus gets USFDA nod for generic medication

The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Estradiol Transdermal System USP in the American market.

Nuvama sees high risk of OAI classification as Lupin facility faces US FDA heat

Domestic pharma companies have been struggling with heightened scrutiny from the US FDA after physical checks resumed post COVID. The FDA's approval is vital for Indian drugmakers as a major chunk of their revenues are made up of sales in the US market.

Lupin gets tentative USFDA approval to market generic valbenazine capsules

The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of valbenazine capsules of strengths 40 mg, 60 mg and 80 mg, the company said in a regulatory filing.

US FDA reportedly denies Neuralink approval to conduct human trials

Apparently the FDA has said that the company would need to resolve safety issues before it will be granted approval

Sun Pharma, Glenmark recall products in US due to manufacturing issues

According to the US health regulator, the Mumbai-based drug major is recalling the affected lot due to ''water leakage'' leading to deviation from current good manufacturing practices (cGMP).

FDA lifts hold on Covaxin's clinical trials in US

The FDA’s earlier decision, in April, to put on hold the trials was based on the US firm’s decision to voluntarily implement a temporary pause in dosing participants of the jab, following the World Health Organisation’s observations on Covaxin manufacturing plants in India.

To boost, or not to boost, that is the complicated question

Weighing the disruption of mild COVID-19 on everyday life is important — though data are sparse on how well a fourth dose might lower the risk of mild infections

Suven Pharma may buy Casper Pharma with FDA-ready plant

The Suven Pharmaceuticals Ltd. stock on Tuesday closed at Rs 569.05, gaining 1.89% or Rs 10.55 over the previous close, on BSE.

US drug regulator denies interference over Pfizer vaccine

The FDA issued an emergency use authorization for the two-dose regimen late on Friday night following reports President Donald Trump had threatened to fire the head of the agency if he didn't act that day.

US FDA asks COVID-19 vaccine developers for two months follow-up data

The agency's advise was released on Tuesday as part of documents posted ahead of a meeting of its expert panel later this month to discuss coronavirus vaccines under development.

Raining USFDA warning letters to Indian drug sites point to intensified regulatory risk

Around 18 pharma companies had received USFDA warning letters for their Indian plants in 2019 alone, these were more than half of the all the warning letters issued by the regulatory agency.

Aurobindo Pharma gets USFDA nod for pain reliever Ibuprofen

Aurobindo Pharma said the estimated market size of ibuprofen capsules OTC is USD 164 million for the twelve months ending March 2018.

Cipla gets USFDA nod for generic Testosterone Cypionate injection

The company has received final approval for its abbreviated new drug application (ANDA) for Testosterone Cypionate injection in the strengths of 100mg/ml and 200mg/ml from the US Food and Drug Administration (USFDA), Cipla said in a filing to BSE.

USFDA approves first product from Glenmark's US plant

The US Food and Drug Administration (USFDA) has provided its first supplemental Abbreviated New Drug Application (ANDA) approval for the company's plant in Monroe, Glenmark said in a statement.

Sanofi and Regeneron's eczema drug gets FDA approval

Global healthcare company Sanofi and Regeneron Pharmaceuticals today announced that the US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) injection to patients suffering from chronic and debilitating form of eczema.

Aurobindo Pharma gets final USFDA approval

"Aurobindo's Guaifenesin and Dextromethorphan Hydrobromide extended-release tablets are the AB rated generic equivalent of Reckitt Benckiser's Mucinex DM tablets. The product will be launched in Q1 FY18 (in US)," it said.

Zydus Cadila gets USFDA nod to market muscle relaxant in US

"The company has received final approval from the US Food and Drug Administration (USFDA) to market tizanidine hydrochloride capsules, USP in strengths of 2mg, 4mg and 6mg," Zydus Cadila said in a regulatory filing today.

Breakthrough drug for Huntington disease drives Neuland up 20%

Analysts believe that Neuland Labs is a supplier of API (active pharma ingredient) to Teva for this drug, which is used in the therapy of Huntington Disease, a disorder related to tardive dyskinesia. If the new drug application is accepted, Neuland will be a key beneficiary.

Lupin gets FDA nod for generic version of Suprep

Suprep follows a split dose regime and Lupin has got approval for Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, all of which are taken to cleanse the colon before colonoscopy in adults. Suprep Bowel Prep Kit has a market of $207 mn in the USA.