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USFDA

USFDA commissioner refuses to offer Covid-19 vaccine timing

Washington, Commissioner of the US Food and Drug Administration (FDA) Stephen Hahn HAS refused to offer a timeline for Covid-19 vaccine, which US President...
Medicines

USFDA approves GSK’s HIV drug

The US Food and Drug Administration approved GlaxoSmithKline’s HIV drug, Rukobia, to treat adult patients who have run out of treatment options.
USFDA

Alembic gets USFDA nod for generic Doxycycline Hyclate tablets

New Delhi: Drug firm Alembic Pharmaceuticals on Wednesday said it has received nod from the US health regulator for generic Doxycycline Hyclate tablets used for the...
USFDA

Alembic gets tentative USFDA nod for generic Rivaroxaban tablets

Alembic Pharmaceuticals said it has received tentative approval from the US health regulator for its generic version of Rivaroxaban tablets used in...
USFDA

Aleor gets USFDA nod for Adapalene Gel USP

Alembic Pharmaceuticals has announced that its joint venture Aleor Dermaceuticals has received approval from the US Food & Drug Administration (USFDA) for...
Medicine

Glenmark gets USFDA nod for Fingolimod capsules

New Delhi: Drug major Glenmark Pharmaceuticals on Friday said it has received final nod from the health regulator for Fingolimod capsules. The capsules are used...
USFDA

USFDA approves video game for treating ADHD in kids

The US Food and Drug Administration has for the first time approved a video game for treating attention deficit hyperactivity disorder in...
Medicine

Alembic gets USFDA nod for generic Deferasirox tablets

New Delhi: Alembic Pharmaceuticals on Tuesday said it has received final approval from the US health regulator for generic Deferasirox tablets used...
Medicine Tablet

USFDA revokes emergency use status of HCQ

(Reuters) - The U.S. Food and Drug Administration on Monday revoked the emergency use authorization for malaria drug hydroxychloroquine as a treatment...
USFDA

Plan to approach USFDA for re-inspection: Lupin

NEW DELHI: Drug major Lupin plans to approach the US health regulator for re-inspection of its manufacturing plants in Goa, Pithampur (Madhya Pradesh) and Somerset (US) in the...
Medicine Injection drug vaccine

Caplin gets USFDA approval for generic Vazculep injection

Caplin Steriles Limited, a subsidiary company of Caplin Point Laboratories Limited, has been granted final approval from the United States Food and...
Medicine Tablet

Lupin receives USFDA’s approval for Albendazole Tablets

Pharma major Lupin announced that it has received approval for its Albendazole Tablets USP, 200 mg, from the United States Food and...
USFDA

USFDA grants orphan drug status to Mexiletine HCL: Lupin

New Delhi: Pharma major Lupin on Monday said the US health regulator has granted orphan drug designation (ODD) to mexiletine hydrochloride (HCL) for the treatment of myotonic disorders. The Mumbai-based company's...
Medicine

Zydus Cadila get USFDA approval for Atazanavir capsules

Zydus Cadila has received final approval from the United State Food and Drugs Administration (USFDA) to market...
USFDA

USFDA issues 9 observations to Aurobindo Pharma

Hyderabad: The US Food and Drug Administration (FDA) has issued a 'Form 483' with nine observations to a manufacturing facility in the...
Medicine

Lupin gets USFDA approval for Meloxicam capsules

Pharma major Lupin announced that it has received approval for its Meloxicam Capsules, 5 mg and 10 mg, from the United States...
USFDA asks five firms to recall diabetes drug

USFDA asks five firms to recall diabetes drug

The U.S. Food and Drug Administration (FDA) said on Thursday it has recommended five pharmaceutical firms to voluntarily recall their diabetes drug...
Cadila gets EIR from USFDA

Cadila gets EIR from USFDA

New Delhi: Drug firm Cadila Healthcare on Thursday said its manufacturing facility at Baddi in Himachal Pradesh has received an establishment inspection report (EIR) from the US health...
USFDA

Indoco receives USFDA approval for Succinylcholine Chloride Inj USP

Indoco Remedies announces receipt of approval of its ANDA for Succinylcholine Chloride Injection, USP 200 mg / 10 ml (20 mg /...
USFDA

USFDA’s relaxation in inspections for Indian pharma

The US Food and Drug Administration (FDA)’s decision to utilize and implement additional alternative inspection tools and approaches while postponing domestic and...

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Lalit Kr. Goel
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N K Ahooja
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Naripen Goyal
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Dr. J K Jha
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Manmohan Taneja
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Rakesh Dahiya
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H. Mahapatra
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Dr. B Suresh
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Dr. P K Sreekumar
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P P Sharma
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P K Jaggi
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