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Results For "United-States-Food-and-Drug-Administration"

396 News Found

Briefs: Lupin and Aurobindo Pharma
News | May 13, 2024

Briefs: Lupin and Aurobindo Pharma

Lupin updates on shipment of Mirabegron ER Tablets


Cipla receives 1 observation from USFDA for Kurkumbh facility
Drug Approval | May 10, 2024

Cipla receives 1 observation from USFDA for Kurkumbh facility

The company is committed to address this observation comprehensively within stipulated time


Gland Pharma receives approval for Edaravone Injection
Drug Approval | May 09, 2024

Gland Pharma receives approval for Edaravone Injection

The product is used to treat amyotrophic lateral sclerosis


Lupin receives USFDA approval for travoprost ophthalmic solution
Drug Approval | May 07, 2024

Lupin receives USFDA approval for travoprost ophthalmic solution

Travoprost Ophthalmic Solution USP, 0.004%, is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.


Briefs: Eugia Pharma Specialities and IOL Chemicals and Pharmaceuticals
Drug Approval | May 06, 2024

Briefs: Eugia Pharma Specialities and IOL Chemicals and Pharmaceuticals

Eugia Pharma Specialities receives 7 observations from USFDA for Unit II


Jubilant Pharmova announces completion of USFDA audit of Radiopharmaceuticals manufacturing facility at Montreal
Drug Approval | April 28, 2024

Jubilant Pharmova announces completion of USFDA audit of Radiopharmaceuticals manufacturing facility at Montreal

The USFDA has issued 5 observations pursuant to the completion of audit


Zydus receives final approval from USFDA for Tretinoin Cream
Drug Approval | April 28, 2024

Zydus receives final approval from USFDA for Tretinoin Cream

The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad (India)


Lupin launches Mirabegron Extended-Release Tablets in US
Drug Approval | April 22, 2024

Lupin launches Mirabegron Extended-Release Tablets in US

Mirabegron Extended-Release Tablets, 25 mg had estimated annual sales of US$ 1,019 million in the US


Zydus launches Mirabegron ER Tablets in the US
Drug Approval | April 22, 2024

Zydus launches Mirabegron ER Tablets in the US

Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market