Page 25 - Usfda

Lupin launches generic rheumatoid arthritis drug 'Leflunomide' in US market

Drug maker Lupin on Wednesday said it has launched Leflunomide tablets, used to treat rheumatoid arthritis, in the US market. The company has launched the product in 10 mg and 20 mg strengths after receiving the approval from the US Food and Drug Administration (USFDA) earlier, Lupin said in a statement. The product would be manufactured at drug maker's Pithampur (Unit I) facility in Madhya Pradesh, it added. The Mumbai-based company's product is the generic equivalent of Sanofi-Aventis US LLC's Arava tablets and is indicated for the treatment of adults with active rheumatoid arthritis (RA). As per IQVIA MAT June data, Leflunomide tablets had an annual sales of around USD 42 million in the US.

Zydus Cadila gets approval from USFDA for muscle relaxant injection

Drugfirm Zydus Cadila has received final approval from the US health regulator to market Cisatracurium BesylateInjection, a muscle relaxant given before general anaesthesia

Traditional firms take on Covid-19 through innovative firsts in market

"Immunity and antiviral have become the key words but consumers are not gullible and if they see through a company's claims, it loses the game even before it has begun it," said Harish Bijoor

Gold prices fall to Rs 51,454 per 10 gram, silver plunges to Rs 64,594 a kg

In New Delhi, prices of 22-carat gold plunged sharply to Rs 51,250 from Rs 51,700 per 10 gram in the previous trade while price of 24-carat was at Rs 54,870

Growth risks

India needs reforms to enhance productivity

Lupin gets USFDA approval for asthmatic symptoms prevention drug

Drug major Lupin on Tuesday said it has received approval from the US health regulator for its Albuterol Sulfate Inhalation Aerosol, used for treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms. The approved product is a generic version of ProAir HFA of Teva Branded Pharmaceutical Products R&D, Inc. In a regulatory filing, Lupin said it has received approval from the United States Food and Drug Administration (USFDA) for its Albuterol Sulfate Inhalation Aerosol, 90 mcg (base)/actuation. Vinita Gupta, CEO, Lupin said: "The approval is timely as Albuterol MDI is a key rescue inhalation product for asthma patients who are at an increased risk of COVID-19-related complications. We look forward to launching the product this quarter and expect a steady ramp-up through the fiscal year. Quoting IQVIA moving annual total June 2020 data, Lupin said the total Albuterol Sulfate Inhalation Aerosol market had US sales of approximately USD 2.9 billion, of which the ...

Why a vaccine that stops coronavirus won't be enough to end the pandemic

A vaccine's ability to forestall a disease is also how vaccine developers typically design - and how regulators typically evaluate - Phase 3 clinical trials for vaccine candidates

Trump to present Covid-19 therapy 'breakthrough' after hitting FDA

Trump claimed on Saturday that Food and Drug Administration employees are causing delays to sabotage his re-election

Trump accuses 'deep state' at FDA of slowing vaccine, to hurt his election

The "deep state" is a term used by Trump to describe employees of government agencies that he believes are manipulating policy to work against his interests

Zydus Cadila gets USFDA nod to market phosphorus controlling drug

Drug firm Zydus Cadila on Thursday said it has received final nod from the US health regulator to market generic Sevelamer Carbonate tablets

Zydus launches cheapest remdesivir at Rs 2,800 per 100 mg vial in India

Potential Covid-19 treatment drug launched under brand name Remdac in India

Lupin, Sun Pharma recalling products in the US market, says USFDA

Leading drug makers Lupin and Sun Pharma are recalling different products in the US, according to the US Food and Drug Administration (USFDA).

Lupin alliance partner Concord gets USFDA nod for generic medicine

Concord has received approval from the US Food and Drug Administration (USFDA) to market the drug to prevent organ transplant rejection

Unichem gets USFDA nod for generic version of tolterodine tartrate tablets

The tolterodine tartrate tablets are generic versions of Pfizer Inc's DETROL tablets

Roche gets USFDA okay for transplant patients Epstein-Barr virus test

Roche has received authorisation from the United States' Food and Drug Administration (FDA) for its cobas 6800/8800 diagnostic tests for transplant patients

Lupin gets US FDA approval to market generic diabetes drug in the US

The Mumbai-based company has received a tentative approval from the USFDA for its Empagliflozin tablets

Zydus Cadila gets tentative USFDA nod to market Parkinson's disease drug

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

Trailing in the value chain: Domestic pharma's unfinished agenda

In the first of a 5-part series, we look at reasons keeping Indian pharma sector from becoming the best globally

Lupin, Granules India recall 971,000 diabetes drug bottles from US market

As per the USFDA, the companies are recalling the product due to deviation from the current good manufacturing practices

Covid-19: Favipiravir triggers a price war; new brand launched at Rs 39

According to industry insiders, many more brands are lined up for launch, including one from Cipla