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Tag: usfda

You Searched For "usfda"
Zydus Lifesciences bags USFDA nod for Azithromycin Tablets to treat certain bacterial infections

Zydus Lifesciences bags USFDA nod for Azithromycin Tablets to treat certain bacterial infections

Ruchika Sharma10 April 2023 4:41 PM IST
The drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, India.
Philips respiratory devices recall classified as most serious by USFDA

Philips respiratory devices recall classified as most serious by USFDA

Ruchika Sharma9 April 2023 11:30 AM IST
Philips was recalling the machines as some devices were assigned incorrect or duplicate serial numbers during initial programming, the US health...
Alkem Launches Olesoft Trucera Lotion to Repair Skin Barrier, Boost Hydration

Alkem Labs Ankleshwar facility clears USFDA inspection

Ruchika Sharma8 April 2023 11:56 AM IST
Mumbai: Through a recent BSE filing, Alkem Labs has informed that the United States Food and Drug Administration (US FDA) has conducted a GMP and...
Setback to Torrent: CDSCO Panel Rejects Phase III Waiver Plea for Prucalopride Over Safety Data Gaps

Torrent Pharma unveils generic version of Keveyis tablets in US

Ruchika Sharma8 April 2023 11:00 AM IST
Dichlorphenamide Tablets are indicated for the treatment of primary hyperkalemic periodic paralysis and related variants.
Zydus Lifesciences bags USFDA approval for Carbidopa and Levodopa Tablets to treat Parkinsons disease symptoms

Zydus Lifesciences bags USFDA approval for Carbidopa and Levodopa Tablets to treat Parkinson's disease symptoms

Ruchika Sharma6 April 2023 2:32 PM IST
The product will be manufactured at the group's formulation manufacturing facility in SEZ Ahmedabad, India.
USFDA nod to Zydus Lifesciences glaucoma drug Acetazolamide

USFDA nod to Zydus Lifesciences glaucoma drug Acetazolamide

Ruchika Sharma6 April 2023 12:30 PM IST
The drug is used with other medicines to reduce edema (excess fluid retention) and to help control seizures in certain types of epilepsy.
Samples of Global Pharma Healthcare eye drops free of contamination: Health Ministry sources

Samples of Global Pharma Healthcare eye drops free of contamination: Health Ministry sources

Ruchika Sharma5 April 2023 3:30 PM IST
"Indian samples tested were found to be of standard quality. We found the samples free of any contamination," source said.
Merck gets USFDA Priority Review for application for Keytruda plus standard of care as Perioperative treatment for Resectable Locally Advanced Head, Neck Squamous Cell Carcinoma

Merck gets USFDA nod for Keytruda in combination with Padcev to treat Advanced or Metastatic Urothelial Cancer

Ruchika Sharma5 April 2023 1:16 PM IST
Rahway: Merck, known as MSD outside of the United States and Canada, has announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA,...
Pfizers Abrocitinib Phase III Data Accepted by CDSCO Expert Committee

USFDA accepts Pfizer supplemental new drug applications for BRAFTOVI plus MEKTOVI

Ruchika Sharma5 April 2023 12:00 PM IST
New York: Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug...
Senores Pharma arm facility gets 3 USFDA observations

Piramal Pharma Digwal facility successfully concludes USFDA inspection

Ruchika Sharma4 April 2023 12:11 PM IST
Mumbai: Piramal Pharma Limited has recently announced that the US Food and Drug Administration (USFDA) has successfully completed the Good...
May cause grave injuries or death: USFDA classifies recall of Getinge heart devices as most serious

May cause grave injuries or death: USFDA classifies recall of Getinge heart devices as most serious

MD Bureau3 April 2023 12:50 PM IST
An estimated 4,502 devices were recalled by the Swedish medical equipment maker's unit, Datascope, in the country in January, according to the US Food...
USFDA approves Abbott Epic Max stented tissue valve to treat aortic regurgitation or stenosis

USFDA approves Abbott Epic Max stented tissue valve to treat aortic regurgitation or stenosis

Ruchika Sharma2 April 2023 5:00 PM IST
Abbott Park, Ill.: Abbott has announced that the U.S. Food and Drug Administration (FDA) has approved the company's Epic Max stented tissue valve to...
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