Sunday, October 17, 2021

USFDA

Third Covid jab likely for highly vulnerable patients

Recently USFDA gave its nod for the use of Pfizer-BioNTech and Moderna Covid vaccines as additional dose on certain immunocompromised individuals

N99 mask 100 per cent Covid-proof!

The use of high-grade face masks sees 100 per cent protection against direct, ward-based Covid-19 infection, says study

Zydus Cadila gets USFDA nod to market HIV infection treatment tablets

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

Ocugen to pursue biologics license application in US for Covaxin

With herd immunity and a significant percentage of the US population vaccinated, the pandemic is reducing, and keeping this in view, the USFDA communicated that no new emergency use authorization would be approved for new Covid-19 vaccines

Glenmark gets USFDA approval for Theophylline ER tablets

The company said the tablet is the bioequivalent and therapeutically equivalent to the Theophylline extended-release tablets, 300 mg and 450 mg, of Alembic Pharmaceuticals Limited.

Glenmark Pharma launches anti-epileptic drug in US

Quoting IQVIA sales data for the 12 month period ending April 2021, Glenmark Pharma said the Banzel tablets, 200 mg and 400 mg market achieved annual sales of approximately USD 285.3 million.

Vaccination key to fight Covid, Manmohan to Modi

He also said that this is the time to invoke the compulsory licensing provisions in the law, so that a number of companies are able to produce the vaccines under a licence

Aurobindo Pharma gets nod for generic capsules

The company has received final approval from USFDA to manufacture and market Droxidopa capsules in the strengths of 100 mg, 200 mg and 300 mg

Lupin, Aurobindo units recall products in US market

Lupin is recalling 46,479 bottles of anti-viral medication Oseltamivir Phosphate for Oral Suspension.

Jubilant recalls antidepressant drug in US

As per the latest Enforcement Report issued by USFDA, the Salisbury-based Jubilant Cadista is recalling the drug for "failed tablet/capsule specification"

Indian drug firms recall various products in US market

As per the USFDA, Marksans Pharma is recalling close to six lakh bottles of diabetes drug Metformin Hydrochloride extended-release tablets in strengths of 500 mg and 750 mg in the US market

USFDA issues 13 observations to Lupin

Lupin said it does not believe that the observations will have an impact on disruption of supplies or the existing revenues from operations of this facility

Zydus Cadila gets nod from USFDA to market diabetes drug

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad, it added. Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control

Remdesivir gets FDA nod

Drug gets approval for use in adults, paediatric patients of 12 years and above and weighing more than 40 kg for Covid treatment

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