Page 24 - Usfda

Granules India gets USFDA approval for potassium chloride tablets

Drug firm Granules India said it has received marketing approval from the US health regulator for Potassium Chloride extended release tablets, used for treatment of patients with hypokalemia

Alembic Pharma JV gets USFDA nod for antifungal topical solution

Drug firm Alembic Pharmaceuticals said its joint venture firm Aleor Dermaceuticals has received final approval from the US health regulator for anti-fungal Tavaborole Topical Solution

Aurobindo Pharma arm's New Jersey unit gets warning letter from USFDA

Drug firm Aurobindo Pharma said its step-down subsidiary has received a warning letter from the US health regulator for its unit in New Jersey, US

Strides Pharma Science arm gets USFDA nod for Ethacrynic Acid tablets

Drug firm Strides Pharma Science on Tuesday said its step down subsidiary has received approval from the US health regulator for Ethacrynic Acid tablets, used to treat fluid retention (edema)

Alembic Pharma gets USFDA nod for anti-viral drug Amantadine Hydrochloride

Drug firm Alembic Pharmaceuticals said it has received approval from the US health regulator for Amantadine Hydrochloride tablets, used for treatment of influenza A virus

Zydus Cadila gets USFDA nod to market Verapamil Hydrochloride Injection

Drug firm Zydus Cadila said it has received final approval from the US health regulator to market Fingolimod capsules and Verapamil Hydrochloride Injection.

Race for coronavirus cure hits reality as clinic complications mount

Regulators and drugmakers have faced questions about whether political pressure was overwhelming scientific rigor ahead of the presidential election on Nov. 3

Pre-US election coronavirus vaccine hopes dim as USFDA asserts power

The FDA said it would demand two months of safety data before it would review any application for a vaccine emergency-use authorisation

FDA discloses coronavirus vaccine guidelines blocked by White House

The Food and Drug Administration laid out updated safety standards for makers of Covid-19 vaccines after the White House blocked their formal release

Lupin gets USFDA nod to market drug for treating relapsing sclerosis

Lupin said it has received approval from the US health regulator to market generic Dimethyl Fumarate delayed-release capsules used for treatment of relapsing forms of multiple sclerosis in adults

White House nixes tougher FDA guidelines on coronavirus vaccine approval

The White House has blocked new FDA guidelines on bringing potential vaccines for Covid-19 to market that would almost certainly have prevented their approval before the Nov 3 election

As domestic sales decline, drug makers focus on exports to sustain growth

During April-July, drug makers exported products worth $ 7.4 billion, a growth of 9.5 per cent on year on year basis

Cipla gets final approval from USFDA for multiple sclerosis drug

Drug major Cipla on Friday said it has received final approval from the US health regulator for Dimethyl Fumarate capsules, indicated for the treatment of relapsing forms of multiple sclerosis. The newly approved product is a generic therapeutic equivalent version of Biogen IDEC Inc's Tecfidera. Cipla has received final approval for its abbreviated new drug application (ANDA) for Dimethyl Fumarate DR (delayed release) capsules in the strengths of 120mg, 240mg and 120mg and 240mg from the United States Food and Drug Administration (USFDA), the company said in a regulatory filing. Quoting IQVIA (IMS Health) data, Cipla said Tecfidera had US sales of approximately USD 3.8 billion for the 12-month period ending July 2020. Shares of Cipla were trading 2.12 per cent higher at Rs 748.35 apiece on the BSE.

Zydus Cadila gets USFDA nod for multiple sclerosis treatment drug

Zydus Cadila said it received approval from the USFDA to market Dimethyl Fumarate delayed release capsules, indicated for the treatment of patients with relapsing forms of multiple sclerosis

Zydus Cadila gets tentative USFDA approval to market anti-cancer drug

Drug firm Zydus Cadila on Thursday said it has received tentative approval from the US health regulator to market anti-cancer drug Palbociclib Capsules

ICMR exploring saliva-based tests to diagnose Covid-19: Harsh Vardhan

Vardhan also said that no significant or drastic mutations had been found in strains of SARS-CoV-2 in India till now

Zydus Cadila gets USFDA nod to market mineral supplement tablets

Zydus Cadila said it has received approval from USFDA to market potassium chloride extended release tablets, a mineral supplement used to treat or prevent low amounts of potassium in the blood

Emergency use authorisation of drugs or vaccines: What, when, how

The US Food and Drug Administration had recently allowed the emergency use of convalescent plasma therapy for Covid treatment, besides existing drugs such as Remdisivir

USFDA's Hahn plans significant work with AstraZeneca in Covid trial inquiry

The top US Food and Drug Administration official confirmed AstraZeneca's US Covid-19 vaccine trial is on hold

Indoco Remedies gets USFDA nod for blood thinning drug Apixaban tablets

Drug firm Indoco Remedies said it has received approval from the US health regulator for blood thinning drug Apixaban tablets