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Tag: usfda

You Searched For "usfda"
FDA approves Zepatier for treatment of chronic hepatitis C genotypes 1 and 4

FDA approves Zepatier for treatment of chronic hepatitis C genotypes 1 and 4

savita29 Jan 2016 2:44 PM IST
The U.S. Food and Drug Administration approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C...
FDA approves Neos Therapeutics long-acting ADHD drug

FDA approves Neos Therapeutics long-acting ADHD drug

savita29 Jan 2016 8:31 AM IST
Neos Therapeutics Inc's drug to treat a common type of childhood behavioral disorder was approved by the U.S. Food and Drug Administration, making it...
Domestic medicines face quality lapses, says govt task force

Domestic medicines face quality lapses, says govt task force

Pooja28 Jan 2016 11:17 AM IST
The task force set up by the department of pharmaceuticals (DoP) under the Indian government banner to monitor the domestic pharmaceutical production,...
Aurobindo Pharma gets USFDA nod for fungal infections tablets

Aurobindo Pharma gets USFDA nod for fungal infections tablets

savita28 Jan 2016 11:02 AM IST
New Delhi: Aurobindo Pharma has received approval from the US health regulator to manufacture and market generic Voriconazole tablets used for the...
FDA gives full approval to Amgen blood cancer drug

FDA gives full approval to Amgen blood cancer drug

savita23 Jan 2016 11:59 AM IST
The U.S. Food and Drug Administration said it has approved Amgen Inc's cancer drug Kyprolis in combination with certain other therapies to treat...
India issues alert to deter use of Roche

India issues alert to deter use of Roche's Avastin drug for eyes

savita23 Jan 2016 11:58 AM IST
New Delhi: India's federal drugs controller issued an alert, asking states to ensure Swiss drugmaker Roche's cancer treatment Avastin was not...
Glenmark Pharma gets USFDA nod for two generic drugs

Glenmark Pharma gets USFDA nod for two generic drugs

savita22 Jan 2016 11:25 AM IST
New Delhi: Glenmark Pharma said it has received final approval from the USFDA to manufacture and market Potassium Chloride extended release capsules...
Aurobindo Pharma gets USFDA nod for two generic drugs

Aurobindo Pharma gets USFDA nod for two generic drugs

savita18 Jan 2016 10:48 AM IST
New Delhi: Drug firm Aurobindo Pharma has received final approval from USFDA to manufacture and market its Tranexamic acid injection and Paricalcitol...
USFDA observations for Shendra facility not critical: Wockhardt

USFDA observations for Shendra facility not critical: Wockhardt

savita18 Jan 2016 9:58 AM IST
New Delhi: The nine observations received by Wockhardt for its Shendra facility in Aurangabad from the US health regulator are not 'critical' in...
USFDA makes 9 observations over Wockhardt

USFDA makes 9 observations over Wockhardt's plant in Shendra

savita16 Jan 2016 10:50 AM IST
New Delhi: The USFDA has made nine 'observations' highlighting violations of its norms at homegrown drug maker Wockhardt's new facility at Shendra in...
FDA clears Olympus duodenoscope with design modifications

FDA clears Olympus duodenoscope with design modifications

savita16 Jan 2016 10:49 AM IST
The U.S. Food and Drug Administration cleared Japan's Olympus Corp's duodenoscope with changes to the device's design and labeling intended to help...
Vyome Bios acne drug VB 1953 gets USFDA nod

Vyome Bio's acne drug VB 1953 gets USFDA nod

savita15 Jan 2016 2:44 PM IST
Mumbai: Bio-pharmaceutical company Vyome Biosciences said the US Food and Drug Administration (USFDA) has cleared its investigational new drug (IND)...
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