Page 11 - Usfda

USFDA issues 13 observations after inspection of Lupin arm's facility in US

Drug firm Lupin said the US health regulator has issued 13 observations after inspection of its subsidiary's Somerset facility in New Jersey

Alembic Pharma gets tentative USFDA nod for breast cancer treatment drug

Drug firm Alembic Pharmaceuticals said it has received tentative approval from the US health regulator for Palbociclib capsules, used to treat a certain type of breast cancer

Cipla posts net profit of Rs 665 cr in Q2, income from ops grows 15%

The company's prescription biz grew 14% YoY supported by continued traction in the Covid portfolio

FDA panel reviews 1st new drug in 2 decades that claims to slow Alzheimer's

One of the biggest drug decisions in decades is looming as US regulators consider whether to approve the first medicine that's claimed to slow mental decline from Alzheimer's disease

USFDA approves Remdesivir as first Covid-19 therapy amid WHO reservations

Approval unlikely to increase prices immediately as Gilead has said licenses are royalty-free until the end of the health emergency

World Coronavirus Dispatch: US FDA approves remdesivir as first Covid drug

Philippines to allow foreign investors in, French curfew now covers two-thirds of its population, mouthwash won't shield you from virus, and other pandemic-related news across the globe

USFDA approves first coronavirus treatment drug - antiviral remdesivir

US regulators approved the first drug to treat COVID-19: remdesivir, an antiviral medicine given through an IV for patients needing hospitalization

Aurobindo Pharma gets USFDA nod for pain treatment injection Acetaminophen

Drug firm Aurobindo Pharma on Thursday said it has received final approval from the US health regulator for its generic Acetaminophen injection, used in the treatment of pain in adult and paediatric patients. The company has received the approval from the US Food & Drug Administration (USFDA) to manufacture and market Acetaminophen injection, 1,000 mg/ 100 mL single-dose vial, Aurobindo Pharma said in a BSE filing. The product will be launched in December 2020, it added. It is a generic version of Mallinckrodt's Ofirmev injection. According to IQVIA data, the approved product has an estimated market size of USD 339 million for the twelve months ending August 2020, Aurobindo Pharma said. Acetaminophen Injection is indicated for the treatment of mild to moderate pain in adult and paediatric patients 2 years and older. It is also set to treat moderate to severe pain with adjunctive opioid analgesics in adult and paediatric patients 2 years and older, and reduction of fever, the ...

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