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Results For "USFDA"

1210 News Found

Alembic announces USFDA approval for Desipramine Hydrochloride Tablets
News | July 09, 2021

Alembic announces USFDA approval for Desipramine Hydrochloride Tablets

The company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA


Zydus Cadila receives USFDA approval for Emtricitabine and Tenofovir Disoproxil
News | July 04, 2021

Zydus Cadila receives USFDA approval for Emtricitabine and Tenofovir Disoproxil

The drug is used with other HIV medications to help control HIV infection and it helps to decrease the amount of HIV in one’s body so that the immune system can work better


Zydus Cadila receives tentative approval from USFDA for Pemetrexed
News | June 26, 2021

Zydus Cadila receives tentative approval from USFDA for Pemetrexed

Pemetrexed is used to treat certain types of cancers such as lung cancer, mesothelioma. It is a chemotherapy drug that works by slowing or stopping the growth of cancer cells


Zydus Cadila receives USFDA approval for Fingolimod capsules
News | June 25, 2021

Zydus Cadila receives USFDA approval for Fingolimod capsules

Fingolimod is an immunomodulating drug. It is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis


Zydus Cadila receives tentative USFDA approval for Brivaracetam
News | June 15, 2021

Zydus Cadila receives tentative USFDA approval for Brivaracetam

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad


Zydus Cadila receives tentative approval from USFDA for lung cancer drugs
Policy | June 03, 2021

Zydus Cadila receives tentative approval from USFDA for lung cancer drugs

Osimertinib works by slowing or stopping the growth of cancer cells and binds to a certain protein (epidermal growth factor receptor-EGFR) in some tumors


NATCO Pharma receives USFDA approval for Lenalidomide capsules
Policy | May 24, 2021

NATCO Pharma receives USFDA approval for Lenalidomide capsules

NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.


Alembic gets USFDA approval for Lurasidone Hydrochloride tablets
News | May 15, 2021

Alembic gets USFDA approval for Lurasidone Hydrochloride tablets

Lurasidone Hydrochloride tablets are also indicated for adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder


Alembic announces USFDA approval for two drugs
News | May 06, 2021

Alembic announces USFDA approval for two drugs

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2% and 0.5% has an estimated market size of US $80 million for twelve months ending December 2020 according to IQVIA


Caplin Steriles gets USFDA approval
News | April 23, 2021

Caplin Steriles gets USFDA approval

The injection comes in multiple formats