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Results For "Food-and-Drug-Administration"

1262 News Found

Zydus receives final approval from the USFDA for Metoprolol Tartrate
Drug Approval | April 21, 2023

Zydus receives final approval from the USFDA for Metoprolol Tartrate

Metoprolol is used with or without other medications to treat high blood pressure (hypertension).


Zydus receives final approval from USFDA for Roflumilast Tablets, 250 mcg
Drug Approval | April 20, 2023

Zydus receives final approval from USFDA for Roflumilast Tablets, 250 mcg

Roflumilast reduces inflammation in the lungs that leads to chronic obstructive pulmonary disease (COPD)


Zydus receives final approval from the USFDA for Estradiol Transdermal System
Drug Approval | April 19, 2023

Zydus receives final approval from the USFDA for Estradiol Transdermal System

Estradiol Transdermal System USP, 0.014 mg/day (weekly) had annual sales of USD 1.9 mn in the United States


Zydus receives final approval from the USFDA for Isoproterenol Hydrochloride Injection
Drug Approval | April 17, 2023

Zydus receives final approval from the USFDA for Isoproterenol Hydrochloride Injection

Isoproterenol hydrochloride injection is indicated to improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output


Moderna and Merck announce an investigational individualized neoantigen therapy
Clinical Trials | April 17, 2023

Moderna and Merck announce an investigational individualized neoantigen therapy

mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of recurrence or death by 44% compared to KEYTRUDA alone in stage III/IV melanoma patients


FDA accepts application for Merck’s Keytruda plus chemotherapy as first-line treatment for metastatic gastric
Drug Approval | April 14, 2023

FDA accepts application for Merck’s Keytruda plus chemotherapy as first-line treatment for metastatic gastric

Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression


Zydus receives final approval from USFDA for Tavaborole Topical Solution
Drug Approval | April 12, 2023

Zydus receives final approval from USFDA for Tavaborole Topical Solution

Tavaborole Topical Solution, 5% had annual sales of US $3.1 million in the United States


Zydus receives final approval from the USFDA for Azithromycin Tablets
Drug Approval | April 11, 2023

Zydus receives final approval from the USFDA for Azithromycin Tablets

Azithromycin Tablets USP, 500 mg had annual sales of US $20 million in the United States


Shilpa Medicare receives USFDA approval for Psoriatic Arthritis Drug
Drug Approval | April 11, 2023

Shilpa Medicare receives USFDA approval for Psoriatic Arthritis Drug

Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.


Zydus receives final approval from the USFDA for Carbidopa and Levodopa Tablets
Drug Approval | April 07, 2023

Zydus receives final approval from the USFDA for Carbidopa and Levodopa Tablets

Carbidopa and Levodopa is used to treat symptoms of Parkinson's disease or Parkinson-like symptoms