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Tag: usfda

You Searched For "usfda"
Alembic Pharma iron tablet Deferasirox gets USFDA nod

Alembic Pharma iron tablet Deferasirox gets USFDA nod

Ruchika Sharma16 Jun 2020 2:58 PM IST
Deferasirox tablets are indicated for the treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload) and for treatment...
USFDA ends emergency use of hydroxychloroquine to treat Covid-19

USFDA ends emergency use of hydroxychloroquine to treat Covid-19

MD Bureau16 Jun 2020 12:37 AM IST
The drugs are traditionally used to treat malaria and certain autoimmune conditions, including lupus and rheumatoid arthritis. These can be taken to...
Lupin to approach USFDA for re-inspection of Goa, Pithampur, US plant

Lupin to approach USFDA for re-inspection of Goa, Pithampur, US plant

Ruchika Sharma15 Jun 2020 12:12 PM IST
The US drug regulator, after inspecting the two sites, had expressed concerns over quality-control procedures that include handling of...
Dr Reddys Labs launches Colchicine Tablets in US

Dr Reddy's Labs launches Colchicine Tablets in US

Ruchika Sharma13 Jun 2020 12:34 PM IST
Dr. Reddy's Colchicine is available in 0.6 mg tablets in bottle count sizes of 30s and 1 00s
Caplin Steriles gets USFDA nod for generic VAZCULEP injection

Caplin Steriles gets USFDA nod for generic VAZCULEP injection

Ruchika Sharma13 Jun 2020 11:00 AM IST
Phenylephrine Hydrochloride Injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the...
Biocon, Mylan get USFDA approval for insulin glargine injection Semglee

Biocon, Mylan get USFDA approval for insulin glargine injection Semglee

Ruchika Sharma12 Jun 2020 1:17 PM IST
Semglee has an identical amino acid sequence to Sanofi's Lantus® and is approved for the same indications
Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension

Lupin gets USFDA nod to anthelmintic drug Albendazole

Ruchika Sharma12 Jun 2020 12:34 PM IST
Mumbai, Baltimore: Drug maker Lupin Limited has received approval for its Albendazole Tablets USP, 200 mg, from the United States Food and Drug...
Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension

Lupin Mexiletine Hydrochloride gets Orphan Drug Designation from USFDA

Ruchika Sharma9 Jun 2020 11:04 AM IST
Mexiletine reduces myotonia symptoms, resulting in a significant improvement in patient quality-of-life and other functional outcomes
Zydus Cadila gets final USFDA nod to HIV infection drug Atazanavir

Zydus Cadila gets final USFDA nod to HIV infection drug Atazanavir

Ruchika Sharma6 Jun 2020 11:29 AM IST
Atazanavir, an antiretroviral drug, is used to treat infection of the Human Immunodeficiency Virus (HIV)
Aurobindo Pharma USA facility gets 9 USFDA observations

Aurobindo Pharma USA facility gets 9 USFDA observations

Ruchika Sharma5 Jun 2020 12:52 PM IST
The company believes that this OAI classification may not have any material impact on the existing revenues, the supplies of our US business, or...
FDA grants breakthrough designation to wearable device  for Restless Legs Syndrome

FDA grants breakthrough designation to wearable device for Restless Legs Syndrome

Dr. Kamal Kant Kohli5 Jun 2020 11:43 AM IST
SAN FRANCISCO - Noctrix Health, Inc., a privately held medical device company announced today that the US Food and Drug Administration (FDA) has...
Mylan, Revance to Advance Development Program for Biosimilar to BOTOX

Mylan, Revance to Advance Development Program for Biosimilar to BOTOX

Ruchika Sharma5 Jun 2020 9:00 AM IST
Mylan and Revance signed a collaboration and license agreement in February 2018 for the development and regulatory approval of a biosimilar to BOTOX,...
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