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Results For "FDA-approval"

438 News Found

Lupin receives USFDA approval for Tiotropium Dry Powder Inhaler
Drug Approval | June 22, 2023

Lupin receives USFDA approval for Tiotropium Dry Powder Inhaler

This product will be manufactured at Lupin's Pithampur facility in India


Biostar Pharma receives FDA approval Utidelone Injectable Phase 2/3 clinical trial for cell lung cancer
Drug Approval | June 20, 2023

Biostar Pharma receives FDA approval Utidelone Injectable Phase 2/3 clinical trial for cell lung cancer

This trial is a multi-national, phase 2/3, open-label, randomized, controlled clinical study of utidelone injectable


Lupin receives USFDA approval from Obeticholic Acid Tablets
Drug Approval | June 01, 2023

Lupin receives USFDA approval from Obeticholic Acid Tablets

Obeticholic Acid Tablets had estimated annual sales of US$ 262 million in the U.S. (IQVIA MAT Mar 2023).


Eugia Pharma receives USFDA approval for Carboprost Tromethamine Injection
Drug Approval | May 27, 2023

Eugia Pharma receives USFDA approval for Carboprost Tromethamine Injection

The product is expected to be launched in June 2023


Ajinomoto Bio-Pharma receives FDA approval for high potency fill line
Drug Approval | April 22, 2023

Ajinomoto Bio-Pharma receives FDA approval for high potency fill line

Aji Bio-Pharma has six fill finish lines located in San Diego, including a new line


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.


Caplin receives USFDA approval for Rocuronium Bromide Injection
Drug Approval | March 21, 2023

Caplin receives USFDA approval for Rocuronium Bromide Injection

Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)


Marksans Pharma announces USFDA approval for Famotidine Tablets
News | March 11, 2023

Marksans Pharma announces USFDA approval for Famotidine Tablets

Marksans' OTC Famotidine Tablets USP are acid reducers


Eugia Pharma receives USFDA approval for Lenalidomide Capsules
Drug Approval | March 09, 2023

Eugia Pharma receives USFDA approval for Lenalidomide Capsules

The approved product is indicated for the treatment of adult patients with Multiple myeloma, in combination with Dexamethasone