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Tag: usfda

You Searched For "usfda"
GE Healthcare gets USFDA clearance for AIR Recon DL with 3D, PROPELLER features

GE Healthcare gets USFDA clearance for AIR Recon DL with 3D, PROPELLER features

Ruchika Sharma5 Oct 2022 12:31 PM IST
Chicago: GE Healthcare has announced US FDA 510(k) clearance of its breakthrough AIR Recon DL for 3D and PROPELLER imaging sequences. The benefits of...
USFDA issues EIR for Suven Pharma arm Casper Parma

USFDA issues EIR for Suven Pharma arm Casper Parma

Ruchika Sharma4 Oct 2022 4:27 PM IST
The inspection concluded with no observation (FDA-483) issued.
Lupin bags USFDA nod for HIV drug Darunavir

Lupin bags USFDA nod for HIV drug Darunavir

Ruchika Sharma4 Oct 2022 3:16 PM IST
The product will be manufactured at Lupin's facility in Nagpur, India.
Zydus Lifesciences US arm bags USFDA nod for generic version of Mirabegron ER tablets

Zydus Lifesciences US arm bags USFDA nod for generic version of Mirabegron ER tablets

Ruchika Sharma3 Oct 2022 12:15 PM IST
Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and urinary frequency.
Lupin gets USFDA EIR for Ankleshwar unit

Lupin gets USFDA EIR for Ankleshwar unit

Ruchika Sharma3 Oct 2022 11:28 AM IST
The inspection of the facility was conducted from August 16-19, 2022.
USFDA issues 2 observations for Zydus Lifesciences arm Ahmedabad facility

USFDA issues 2 observations for Zydus Lifesciences arm Ahmedabad facility

Ruchika Sharma1 Oct 2022 2:30 PM IST
Ahmedabad: Pharma major, Zydus Lifesciences, has recently announced that the US Food and Drug Administration (USFDA) has concluded a Pre-Approval...
Zydus Lifesciences bags USFDA nod for Sildenafil for Oral Suspension

Zydus Lifesciences bags USFDA nod for Sildenafil for Oral Suspension

Ruchika Sharma1 Oct 2022 12:10 PM IST
The drug will be manufactured at the group’s formulation manufacturing facility at Baddi, Himachal Pradesh, India.
Sanofi Prurigo nodularis drug Dupixent gets USFDA okay

Sanofi Prurigo nodularis drug Dupixent gets USFDA okay

Ruchika Sharma30 Sept 2022 4:30 PM IST
Paris: Sanofi has announced that the U.S. Food and Drug Administration (USFDA) has approved Dupixent (dupilumab) for the treatment of adult patients...
Lupin bags tentative USFDA nod for rare autoimmune disorder drug Amifampridine

Lupin unveils generic equivalent of Revatio for Oral Suspension in US

Ruchika Sharma30 Sept 2022 3:30 PM IST
The medication is used to treat erectile dysfunction and pulmonary arterial hypertension.
Lupin bags USFDA approval for Mirabegron ER tablets to treat overactive bladder

Lupin bags USFDA approval for Mirabegron ER tablets to treat overactive bladder

Ruchika Sharma30 Sept 2022 11:28 AM IST
The product will be manufactured at Lupin's facility in Nagpur, India.
USFDA inspection: Lupin gets warning letter for Tarapur facility

USFDA inspection: Lupin gets warning letter for Tarapur facility

Ruchika Sharma29 Sept 2022 2:30 PM IST
Mumbai: Pharma major, Lupin, has announced that the Company has received a warning letter from the US Food and Drug Administration (USFDA)...
Torrent Pharma gets 3 observations from USFDA for Gujarat facility

Torrent Pharma gets 3 observations from USFDA for Gujarat facility

Ruchika Sharma29 Sept 2022 1:15 PM IST
Ahmedabad: Drugmaker, Torrent Pharma, has recently announced that the US Food and Drug Administration (USFDA) has issued a "Form 483" with 3...
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