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Results For "USFDA"

1210 News Found

Zydus receives  USFDA  approval for Phase2(b)/3 trial of Saroglitazar
Biotech | December 10, 2021

Zydus receives USFDA approval for Phase2(b)/3 trial of Saroglitazar

Saroglitazar Mg is an investigational compound in the USA, and is yet to be approved by the U.S. Food & Drug Administration (USFDA) or European Medicines Agency (EMA)


Alembic receives tentative USFDA approval for Selexipag tablets
Drug Approval | December 09, 2021

Alembic receives tentative USFDA approval for Selexipag tablets

The tablets are indicated for the treatment of pulmonary arterial hypertension


USFDA authorises Astra’s antibody cocktail to prevent Covid
Drug Approval | December 09, 2021

USFDA authorises Astra’s antibody cocktail to prevent Covid

Evusheld is a combination of two long-acting monoclonal antibodies and is the only antibody therapy authorised in the US to prevent Covid-19


Zydus gets USFDA approval for arthritis drug
News | August 23, 2021

Zydus gets USFDA approval for arthritis drug

Zydus was the first to file an ANDA for Tofacitinib extended-release tablets 22 mg and currently holds 180-day exclusivity on this strength


USFDA grants full approval for Pfizer-BioNTech Covid-19 vaccine
News | August 23, 2021

USFDA grants full approval for Pfizer-BioNTech Covid-19 vaccine

The vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of Covid-19 disease


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