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Tag: usfda

You Searched For "usfda"
Dr Reddys labs gets USFDA 3 observations for New York API facility

Dr Reddy's labs gets USFDA 3 observations for New York API facility

Ruchika Sharma11 March 2021 12:21 PM IST
New Delhi: Dr Reddy's Laboratories on Wednesday said the US health regulator has issued a Form 483 with three observations after inspecting its...
FDA approves  wearable device for Treatment of acute Israelne

FDA approves wearable device for Treatment of acute Israelne

Dr. Kamal Kant Kohli6 March 2021 8:55 AM IST
Israel: Food and Drug Administration (FDA) has cleared Relivion® system, the first non-invasive multi-channel brain neuromodulation system for at home...
Unichem Labs gets USFDA nod for hypertension drug Guanfacine

Unichem Labs gets USFDA nod for hypertension drug Guanfacine

Ruchika Sharma5 March 2021 12:01 PM IST
Mumbai: Drugmaker, Unichem Laboratories Limited, has recently announced that the company has received abbreviated new drug application...
Alembic Pharma JV Aleor Derma gets USFDA approval for Testosterone Gel

Alembic Pharma JV Aleor Derma gets USFDA approval for Testosterone Gel

Ruchika Sharma4 March 2021 12:29 PM IST
Vadodara: Pharma Major, Alembic Pharma, today announced that the company's joint venture Aleor Dermaceuticals Limited has received final approval...
Cipla bags USFDA nod for Sumatriptan Nasal Spray to treat migraine

Cipla bags USFDA nod for Sumatriptan Nasal Spray to treat migraine

Ruchika Sharma2 March 2021 11:43 AM IST
Mumbai: Drugmaker, Cipla Limited, today announced that the company has received final approval for its Abbreviated New Drug Application (ANDA)...
AstraZeneca discontinues Phase 3 trial of prostate cancer drug Truqap

EU audits Serum Institute of India as AstraZeneca looks to boost supplies to bloc: Source

Ruchika Sharma1 March 2021 6:12 PM IST
New Delhi: Europe's drug regulator is auditing the manufacturing site of the Serum Institute of India (SII), a source with knowledge of the matter...
J&J gets US CDC Advisory Committee Recommendation for single-shot COVID-19 vaccine

J&J gets US CDC Advisory Committee Recommendation for single-shot COVID-19 vaccine

Ruchika Sharma1 March 2021 12:46 PM IST
New Brunswick: Johnson & Johnson has recently announced that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on...
Zydus Cadila secures USFDA nod for Nortriptyline Hydrochloride Capsules

Zydus Cadila secures USFDA nod for Nortriptyline Hydrochloride Capsules

Ruchika Sharma27 Feb 2021 10:00 AM IST
Ahmedabad: Drugmaker, Zydus Cadila, has recently announced that the company has received final approval from the USFDA to market Nortriptyline...
Granules India gets USFDA nod for Acetaminophen, Aspirin, Caffeine Tablets to treat migraine

Granules India gets USFDA nod for Acetaminophen, Aspirin, Caffeine Tablets to treat migraine

Ruchika Sharma25 Feb 2021 12:26 PM IST
Acetaminophen, Aspirin and Caffeine Tablets are indicated for the treatment of migraine.
Strides Pharma Science arm gets USFDA nod for Ibuprofen OTC Oral Suspension

Strides Pharma Science arm gets USFDA nod for Ibuprofen OTC Oral Suspension

Medical Dialogues Bureau25 Feb 2021 11:31 AM IST
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain from various conditions such as headache, dental pain, muscle aches.
AstraZeneca discontinues Phase 3 trial of prostate cancer drug Truqap

AstraZeneca voluntarily withdraws antibody Imfinzi indication for bladder cancer in US

Ruchika Sharma24 Feb 2021 1:37 PM IST
UK: AstraZeneca has recently announced the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for previously treated adult patients...
Sun Pharma Advanced Research Company application for cancer drug Taclantis denied by USFDA

Sun Pharma Advanced Research Company application for cancer drug Taclantis denied by USFDA

Ruchika Sharma24 Feb 2021 1:18 PM IST
New Delhi: Sun Pharma Advanced Research Company Ltd on Tuesday said the USFDA has ruled against its appeal related to Taclantis, its under...
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