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Results For "USFDA"

1404 News Found

USFDA grants distinct indication for Chronic Sleep Disorder
Drug Approval | August 13, 2021

USFDA grants distinct indication for Chronic Sleep Disorder

Idiopathic hypersomnia is a life-long condition, and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this debilitating disorder


Cipla receives USFDA approval for Difluprednate Ophthalmic Emulsion 0.05%
Drug Approval | August 12, 2021

Cipla receives USFDA approval for Difluprednate Ophthalmic Emulsion 0.05%

It’s an AB-rated generic therapeutic version of Durezol


Alembic gets USFDA nod for Clomipramine Hydrochloride
News | August 05, 2021

Alembic gets USFDA nod for Clomipramine Hydrochloride

It had an estimated market size of US $ 32 million as of June 2021


Zydus Cadila receives approval from USFDA for Fulvestrant Injection
News | July 31, 2021

Zydus Cadila receives approval from USFDA for Fulvestrant Injection

The group now has 320 approvals and has so far filed over 400 ANDAs


Caplin gets USFDA approval for Sumatriptan
News | July 15, 2021

Caplin gets USFDA approval for Sumatriptan

Sumatriptan Injection USP is indicated in adults for acute treatment of migraine with or without aura, and acute treatment of cluster headache


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