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Tag: usfda

You Searched For "usfda"
Alembic Pharma JV bags USFDA nod for Efinaconazole Topical Solution

Alembic Pharma JV bags USFDA nod for Efinaconazole Topical Solution

Ruchika Sharma9 April 2021 11:33 AM IST
Vadodara: Alembic Pharmaceuticals Limited has recently announced that the company's joint venture Aleor Dermaceuticals Limited has received tentative...
Zydus Macitentan gets USFDA okay, eligible for 180 days of shared generic drug exclusivity

Zydus Macitentan gets USFDA okay, eligible for 180 days of shared generic drug exclusivity

Ruchika Sharma8 April 2021 12:20 PM IST
Ahmedabad: Pharma major, Zydus Cadila, today announced that the company has received final approval from the United States Food and Drug...
Zydus Cadila cancer drug Ibrutinib secures USFDA nod

Zydus Cadila cancer drug Ibrutinib secures USFDA nod

Ruchika Sharma8 April 2021 11:30 AM IST
For Ibrutinib Capsules, 140 mg, the company will have 180-days of shared generic drug exclusivity.
Dr Reddys launches Sapropterin Dihydrochloride Powder for Oral Solution in US

Dr Reddys launches Sapropterin Dihydrochloride Powder for Oral Solution in US

Ruchika Sharma7 April 2021 4:54 PM IST
Hyderabad: Drug major, Dr. Reddy's Laboratories Ltd., today announced the launch of Sapropterin Dihydrochloride Powder for Oral Solution, 100mg in...
Supernus Pharma ADHD drug Qelbree gets USFDA okay

Supernus Pharma ADHD drug Qelbree gets USFDA okay

Ruchika Sharma6 April 2021 4:02 PM IST
Supernus wouldn't disclose the drug's list price, but it's sure to be higher than the many chegeneric ADHD pills.
Kite seeks USFDA nod for Tecartus to treat Leukemia

Kite seeks USFDA nod for Tecartus to treat Leukemia

Ruchika Sharma4 April 2021 10:15 AM IST
Santa Monica: Kite, a Gilead Company, has recently announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S....
USFDA authorizes up to 15 doses per vial of Moderna COVID-19 vaccine

USFDA authorizes up to 15 doses per vial of Moderna COVID-19 vaccine

Ruchika Sharma3 April 2021 11:30 AM IST
Cambridge: Pharma major, Moderna, has recently announced that based on submitted stability data, the U.S. Food and Drug Administration (FDA) has...
Sanofi gets USFDA nod for Sarclisa, Carfilzomib, Dexamethasone combo to treat multiple myeloma

Sanofi gets USFDA nod for Sarclisa, Carfilzomib, Dexamethasone combo to treat multiple myeloma

Ruchika Sharma3 April 2021 11:00 AM IST
Paris: Sanofi has announced that the U.S. Food and Drug Administration (USFDA) has approved Sarclisa (isatuximab) in combination with carfilzomib and...
Setback: Johnson and Johnson COVID-19 vaccine batch fails quality test

Setback: Johnson and Johnson COVID-19 vaccine batch fails quality test

Ruchika Sharma1 April 2021 1:35 PM IST
J&J said the Emergent BioSolutions factory involved had not yet been approved by the U.S. Food and Drug Administration to make part of the vaccine.
Alembic Pharma JV gets USFDA nod to Nystatin and Triamcinolone Acetonide Cream

Alembic Pharma JV gets USFDA nod to Nystatin and Triamcinolone Acetonide Cream

Ruchika Sharma1 April 2021 12:38 PM IST
Mumbai: Drug major, Alembic Pharmaceuticals Limited, today announced that the company's joint venture Aleor Dermaceuticals Limited has received...
Zydus, Alembic Pharma recall drugs in US over life-threatening consequences

Zydus, Alembic Pharma recall drugs in US over life-threatening consequences

Ruchika Sharma31 March 2021 11:58 AM IST
New Delhi: US-based arms of domestic pharma firms Zydus Cadila and Alembic Pharmaceuticals are recalling one drug each in the US after receiving...
FDA allows marketing of Device to Improve Gait in Multiple Sclerosis Patients

FDA allows marketing of Device to Improve Gait in Multiple Sclerosis Patients

Hina Zahid30 March 2021 8:56 AM IST
The U.S. Food and Drug Administration has authorized marketing of a new device indicated for use as a short-term treatment of gait deficit due to mild...
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