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Tag: usfda

You Searched For "usfda"
AstraZeneca new tablet formulation of Calquence gets USFDA okay

AstraZeneca new tablet formulation of Calquence gets USFDA okay

Ruchika Sharma8 Aug 2022 12:30 PM IST
"The tablet can be taken with gastric acid-reducing agents, including proton pump inhibitors (PPIs), antacids and H2-receptor antagonists (H2RAs),"...
Pfizer, Myovant Sciences get USFDA nod for MYFEMBREE

Pfizer, Myovant Sciences get USFDA nod for MYFEMBREE

Ruchika Sharma7 Aug 2022 11:30 AM IST
MYFEMBREE offers an effective, once-daily treatment option for the management of moderate to severe pain associated with endometriosis, with a...
Janssen bags USFDA nod for psoriatic arthritis treatment STELARA for pediatric patients

Janssen bags USFDA nod for psoriatic arthritis treatment STELARA for pediatric patients

Rahul Verma6 Aug 2022 8:16 PM IST
The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the U.S. Food and Drug Administration (USFDA) has approved STELARA...
Zydus Ahmedabad facility gets 4 USFDA observations

Zydus Ahmedabad facility gets 4 USFDA observations

Ruchika Sharma6 Aug 2022 11:26 AM IST
Ahmedabad: Zydus Lifesciences has recently announced that the US Food and Drug Administration (USFDA) has issued four observations after the...
Jubilant Pharmova Roorkee facility gets 6 USFDA observations

Jubilant Pharmova Roorkee facility gets 6 USFDA observations

Rahul Verma5 Aug 2022 4:12 PM IST
Jubilant Pharmova Limited has announced that the United States Food and Drug Administration (USFDA) has recently concluded audit of the Solid Dosage...
Aurobindo Pharma gets USFDA EIR for Hyderabad facility

Aurobindo Pharma gets USFDA EIR for Hyderabad facility

Ruchika Sharma5 Aug 2022 2:09 PM IST
New Delhi: Aurobindo Pharma has recently announced that the company has received an Establishment Inspection Report (EIR) from the USFDA with...
USFDA nod to Zydus Diabetes drug Empagliflozin

USFDA nod to Zydus Diabetes drug Empagliflozin

Ruchika Sharma4 Aug 2022 3:45 PM IST
The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.
Zydus Lifesciences bags USFDA nod for Ivermectin Cream for treatment of inflammatory lesions of rosacea

Zydus Lifesciences bags USFDA nod for Ivermectin Cream for treatment of inflammatory lesions of rosacea

Ruchika Sharma4 Aug 2022 2:51 PM IST
Ivermectin Cream is used for the treatment of inflammatory lesions of rosacea.
Jubilant Therapeutics gets USFDA clearance for JBI-778 to treat solid tumors with brain metastases, primary brain tumors

Jubilant Therapeutics gets USFDA clearance for JBI-778 to treat solid tumors with brain metastases, primary brain tumors

Ruchika Sharma4 Aug 2022 1:45 PM IST
Bedminster: Jubilant Therapeutics Inc., a biopharmaceutical company has announced U.S. Food and Drug Administration (USFDA) clearance of the...
Janssen gets USFDA nod for psoriatic arthritis treatment STELARA for pediatric patients

Janssen gets USFDA nod for psoriatic arthritis treatment STELARA for pediatric patients

Ruchika Sharma4 Aug 2022 11:46 AM IST
STELARA is administered as a subcutaneous injection dosed four times per year after two starter doses for the treatment of pediatric patients six...
Strides Pharma Science arm bags USFDA nod for Cyclosporine Softgel Capsules

Strides Pharma Science arm bags USFDA nod for Cyclosporine Softgel Capsules

Ruchika Sharma3 Aug 2022 3:00 PM IST
The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.
Aurobindo Pharma gets 3 USFDA observations for Andhra Pradesh facility

Aurobindo Pharma gets 3 USFDA observations for Andhra Pradesh facility

Ruchika Sharma3 Aug 2022 1:10 PM IST
Hyderabad: Aurobindo Pharma has recently announced that the United States Food and Drug Administration (USFDA) has issued FORM 483 with 3 observations...
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