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Tag: usfda

You Searched For "usfda"
Sanofi Enjaymo gets USFDA okay for cold agglutinin disease

Sanofi Enjaymo gets USFDA okay for cold agglutinin disease

Ruchika Sharma8 Feb 2022 11:43 AM IST
The US list price, or wholesale acquisition cost, of Enjaymo is $1,800 per vial.
Azurity Pharma gets USFDA nod for FLEQSUVY

Azurity Pharma gets USFDA nod for FLEQSUVY

Ruchika Sharma8 Feb 2022 10:00 AM IST
Woburn: Azurity Pharmaceuticals, a private specialty pharmaceutical company, has recently announced the U.S. Food and Drug Administration (USFDA)...
Alembic Pharma bags USFDA nod for Fesoterodine Fumarate ER Tablets

Alembic Pharma bags USFDA nod for Fesoterodine Fumarate ER Tablets

Ruchika Sharma3 Feb 2022 1:08 PM IST
Vadodara: Drug maker, Alembic Pharmaceuticals Limited, has recently announced that the company has received tentative approval from the US Food...
Alembic Pharma Clarithromycin tablets get USFDA okay

Alembic Pharma Clarithromycin tablets get USFDA okay

Ruchika Sharma1 Feb 2022 3:48 PM IST
Vadodara: Drug maker, Alembic Pharmaceuticals Limited today announced that the company has received final approval from the US Food & Drug...
Roche gets USFDA nod for injectable eye medicine Vabysmo

Roche gets USFDA nod for injectable eye medicine Vabysmo

Ruchika Sharma1 Feb 2022 1:37 PM IST
Basel: Roche has recently announced that the U.S. Food and Drug Administration (USFDA) has approved Vabysmo (faricimab-svoa) for the treatment of...
Granules India arm gets 3 USFDA observations for Chantilly facility

Granules India arm gets 3 USFDA observations for Chantilly facility

Ruchika Sharma31 Jan 2022 1:02 PM IST
Hyderabad: Granules India Limited announced that Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of the company, located in...
Empowered Diagnostics recalls COVID tests, says USFDA

Empowered Diagnostics recalls COVID tests, says USFDA

Ruchika Sharma30 Jan 2022 10:00 AM IST
New Delhi: Empowered Diagnostics LLC is recalling its COVID-19 tests as they have not been cleared for use in the United States and could potentially...
Granules India secures USFDA nod for Potassium Chloride for Oral Solution

Granules India secures USFDA nod for Potassium Chloride for Oral Solution

Ruchika Sharma28 Jan 2022 4:16 PM IST
Hyderabad: Granules India Limited announced today that the US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug...
Glenmark bags USFDA nod for Metronidazole Vaginal Gel

Glenmark bags USFDA nod for Metronidazole Vaginal Gel

Ruchika Sharma28 Jan 2022 11:12 AM IST
Mumbai: Drug maker, Glenmark Pharmaceuticals Inc., USA has received final approval from the United States Food & Drug Administration...
Aurobindo Pharma in trouble for manufacturing lapses at API plant

Aurobindo Pharma in trouble for manufacturing lapses at API plant

Ruchika Sharma28 Jan 2022 10:00 AM IST
The USFDA pointed at failure of the company's quality unit to ensure that critical deviations are investigated and resolved.
Philips expanded ventilator recall classified as most serious by USFDA

Philips expanded ventilator recall classified as most serious by USFDA

Ruchika Sharma27 Jan 2022 12:45 PM IST
A Philips supplier had incorrectly used a type of polyurethane foam in one of the parts of Trilogy Evo ventilators - an issue that was identified...
Glenmark bags USFDA nod for generic version of Ziac Tablets

Glenmark bags USFDA nod for generic version of Ziac Tablets

Ruchika Sharma27 Jan 2022 10:45 AM IST
Mumbai: Glenmark Pharmaceuticals Inc., USA has received final approval from the United States Food & Drug Administration (USFDA) for Bisoprolol...
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