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Tag: usfda

You Searched For "usfda"
Caplin Steriles bags USFDA nod for Rocuronium Bromide Injection

Caplin Steriles bags USFDA nod for Rocuronium Bromide Injection

Ruchika Sharma3 March 2023 1:30 PM IST
Rocuronium Bromide Injection is a neuromuscular blocking agent, indicated as an adjunct to general anesthesia to facilitate both rapid sequence and...
Zydus Lifesciences cold sores cream Acyclovir bags USFDA okay

Zydus Lifesciences cold sores cream Acyclovir bags USFDA okay

Ruchika Sharma3 March 2023 11:28 AM IST
The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad.
Pfizers Abrocitinib Phase III Data Accepted by CDSCO Expert Committee

Pfizer, BioNTech submit application to USFDA for emergency use nod of Omicron BA.4/BA.5-adapted bivalent COVID booster in children under 5 years

Ruchika Sharma2 March 2023 4:15 PM IST
New York: Pfizer Inc. and BioNTech SE have submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use...
Janssen-Cilag Guselkumab receives UK nod for Crohns disease, ulcerative colitis

Janssen seeks USFDA nod for Niraparib and Abiraterone Acetate Dual-Action Tablet, plus Prednisone to treat patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Gene Mutations

Ruchika Sharma2 March 2023 3:15 PM IST
Metastatic castration-resistant prostate cancer characterizes cancer that no longer responds to androgen deprivation therapy and has spread to other...
Caplin Steriles gets USFDA nod for Procainamide Hydrochloride Injection for treating abnormal heart rhythm

Sanofi, Regeneron Pharma bag USFDA nod for Kevzara to treat polymyalgia rheumatica

Ruchika Sharma2 March 2023 1:15 PM IST
Polymyalgia rheumatica often initially presents with pain and stiffness around the neck, shoulder and hip area and symptoms include fatigue, low-grade...
Indoco Remedies CRO AnaCipher gets one Form 483 from USFDA

Indoco Remedies receives 4 USFDA observations for Goa facilities

Ruchika Sharma2 March 2023 11:29 AM IST
Mumbai: Indoco Remedies Limited has announced that the United States Food and Drug Administration (USFDA) has issued four observations...
Alembic Pharma appoints Jigr Shah as Head - Business Finance

USFDA approves Alembic Pharma anti-cancer injection Docetaxel

Ruchika Sharma1 March 2023 3:12 PM IST
Docetaxel Injections are indicated for the breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma and...
Caplin Steriles gets USFDA nod for Procainamide Hydrochloride Injection for treating abnormal heart rhythm

Zydus Lifesciences Hypertension drug gets USFDA okay

Ruchika Sharma1 March 2023 1:15 PM IST
The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.
Zydus Told To Conduct Phase III Trial in India for Lurbinectedin Injection, BE Study Waived

Zydus Lifesciences bags USFDA nod for Apixaban Tablets to treat blood clots in veins of legs or lungs

Ruchika Sharma1 March 2023 11:17 AM IST
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad.
Pfizer Told To Conduct Phase IV Trial of Abrocitinib in Indian Adolescents with Atopic Dermatitis

Pfizer RSV vaccine for elderly linked to Guillain-Barre risk, says USFDA

MD Bureau27 Feb 2023 4:30 PM IST
Pfizer stated that its shot is a "well-tolerated and safe vaccine, with a benefit-to-risk ratio that is favourable".
Granules India bags USFDA okay for hypertension drug Losartan Potassium

Granules India bags USFDA okay for hypertension drug Losartan Potassium

Ruchika Sharma27 Feb 2023 11:34 AM IST
Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood...
Pfizer Told To Conduct Phase IV Trial of Abrocitinib in Indian Adolescents with Atopic Dermatitis

Pfizer, BioNTech seek USFDA nod for Omicron BA.4/BA.5-Adapted Bivalent COVID vaccine for ages 12 years and older as primary series or booster

Ruchika Sharma25 Feb 2023 12:30 PM IST
New York: Pfizer Inc. and BioNTech SE have announced that they have submitted a supplemental Biologics License Application (sBLA) to the U.S....
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