News for 'United States Food and Drug Administration'

'My job is not to represent the world; my job is to represent the United States of America'

'My job is not to represent the world; my job is to represent the United States of America'

Rediff.com1 Mar 2017

The following is the full text of US President Donald Trump's first address to a joint session of the Congress on February 28, as prepared for delivery and released by the White House press office.

Policy tweaks in US shift Indian pharma's focus

Policy tweaks in US shift Indian pharma's focus

Rediff.com18 Jun 2014

As marketing rights for off-patent drugs in the US become less exclusive, companies are scrambling for fresh strategies to make up for the revenue loss.

J&J in talks with India for study of single-dose vaccine

J&J in talks with India for study of single-dose vaccine

Rediff.com9 Apr 2021

India is currently using two vaccines for COVID-19 -- one developed by Oxford University and AstraZeneca and the other developed by Bharat Biotech in collaboration with the Indian Council of Medical Research-National Institute of Virology. Both the vaccines are being manufactured within the country by domestic firms.

Glenmark gets USFDA final nod for contraceptive tablets

Glenmark gets USFDA final nod for contraceptive tablets

Rediff.com15 Jun 2015

It is the generic version of Teva Women's Health's Seasonale tablets

Taking anti-malarial drug to protect against virus: Trump

Taking anti-malarial drug to protect against virus: Trump

Rediff.com19 May 2020

Soon after Trump revealed to the world that he has been taking the medicine, the White House doctor said the president is in good health.

COVID-19: Remdesivir will be available from next week

COVID-19: Remdesivir will be available from next week

Rediff.com4 May 2020

The EUA allows for Remdesivir to be distributed in the US and administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalised with severe condition.

Covovax nod to boost vaccination drive in India: SII

Covovax nod to boost vaccination drive in India: SII

Rediff.com28 Dec 2021

Vaccine major Serum Institute of India on Tuesday said the approval for the COVID-19 vaccine 'Covovax' would strengthen immunization initiatives across India and various lower and middle income countries across the world.

Indians Dominate TIME 100 AI Titans List

Indians Dominate TIME 100 AI Titans List

Rediff.com23 Sep 2024

The TIME 100 AI list is an interesting assortment of titans. Indians make up about 20 per cent of the coveted list, which is pretty commendable, notes Sandeep Goyal.

Lupin launches generic Ciprofloxacin in US market

Lupin launches generic Ciprofloxacin in US market

Rediff.com13 Jun 2014

The company's US subsidiary, Lupin Pharmaceuticals Inc has launched its Ciprofloxacin for oral suspension in the US market in the strengths of 5 g/100 mL (250mg/5 mL) and 10 g/100 mL (500 mg/5 mL), Lupin said in a statement.

Maha suspends licences of 6 cough syrup manufacturers for rule breach

Maha suspends licences of 6 cough syrup manufacturers for rule breach

Rediff.com4 Mar 2023

Rathod said the Maharashtra government had initiated an inquiry against 84 out of 108 manufacturers of cough syrups in the state.

Orion files suit against Wockhardt

Orion files suit against Wockhardt

Rediff.com12 Dec 2008

The Finland-based drug major Orion Corporation has filed a lawsuit in the United States against domestic drug major Wockhardt for challenging the patents on its brand Stalevo, used for the treatment of Parkinson's disease.

Indian pharma companies bullish in the US

Indian pharma companies bullish in the US

Rediff.com6 Mar 2009

Despite the ongoing trouble India's largest drug maker, Ranbaxy, is facing in the United States, domestic pharmaceutical companies are betting high on the world's largest drug market with added vigour.

GlaxoSmithKline sues Dr Reddy's

GlaxoSmithKline sues Dr Reddy's

Rediff.com31 Dec 2003

GlaxoSmithKline has filed a lawsuit in a United States court against Dr Reddy's Laboratories alleging infringement of patent rights of a generic version of 'Imitrex' drug, used for the treatment of migraine.

Anti-malarial drug a 'line of defence' against virus: Trump

Anti-malarial drug a 'line of defence' against virus: Trump

Rediff.com20 May 2020

The US president said the drug has gotten a bad reputation only because 'he was promoting it'.

USFDA bans more products from Ranbaxy

USFDA bans more products from Ranbaxy

Rediff.com24 Jan 2014

The move follows an FDA inspection of a Ranbaxy facility which identified significant violations of sound manufacturing practices.

AstraZeneca files suit against Ranbaxy

AstraZeneca files suit against Ranbaxy

Rediff.com22 Nov 2005

Global pharma firm AstraZeneca on Tuesday said it had filed a lawsuit in the United States District Court of New Jersey

Kejriwal stopped taking insulin before his arrest: Tihar officials

Kejriwal stopped taking insulin before his arrest: Tihar officials

Rediff.com20 Apr 2024

The Delhi minister also claimed that Kejriwal used to take 50 units of insulin daily before he was sent to jail.

Dr Reddy's files for generic Allegra in US

Dr Reddy's files for generic Allegra in US

Rediff.com26 Mar 2003

Indian drugmaker Dr Reddy's Laboratories Ltd said on Wednesday it has filed with the US Food and Drug Administration to market a generic version of Aventis Pharmaceuticals' anti-allergy drug Allegra.

Hetero's generic version of remdesivir to be sold @ Rs 5,400/vial

Hetero's generic version of remdesivir to be sold @ Rs 5,400/vial

Rediff.com24 Jun 2020

The company is set to deliver the first set of 20,000 vials in two equal lots of 10,000 each, one of which will be immediately supplied to Hyderabad, Delhi, Gujarat, Tamil Nadu, Mumbai and other parts of Maharashtra, Hetero Healthcare said in a statement.

Ranbaxy sues US FDA for revoking drug approvals

Ranbaxy sues US FDA for revoking drug approvals

Rediff.com18 Nov 2014

FDA had cancelled Ranbaxy's approvals to launch generic Nexium, Valcyte

India probes eye drop linked to vision loss in US

India probes eye drop linked to vision loss in US

Rediff.com4 Feb 2023

A three-member team each from the Central Drugs Standard Control Organisation (CDSCO) and the State Drug Controller visited the plant in Tamil Nadu's Kancheepuram, 40 km from Chennai, on Friday after the company recalled the eye drop.

NRI's energy drink under scanner for 13 deaths in US

NRI's energy drink under scanner for 13 deaths in US

Rediff.com16 Nov 2012

A popular energy drink, produced by a company founded by an Indian-American billionaire, has come under the scanner in the United States after reports of 13 deaths possibly linked to the energy shots.

US sees red over sindoor

US sees red over sindoor

Rediff.com19 Dec 2007

Indian women may consider it sacred to adorn 'Sindoor' (vermilion) on their foreheads, but the United States government has warned against using a particular brand of this toxic 'red powder' due to high lead content.

US allows Ranbaxy to market flecainide acetate

US allows Ranbaxy to market flecainide acetate

Rediff.com1 Apr 2003

In a major boost to Ranbaxy Laboratories' exports to developed countries, the United States has approved marketing of flecainide acetate tablets in the country.

US regulators recommend pause on J&J vaccine over rare blood clots

US regulators recommend pause on J&J vaccine over rare blood clots

Rediff.com13 Apr 2021

In a joint statement, the CDC and the FDA said they were investigating clots in six women in the days after vaccination, in combination with reduced platelet count.

Sun Pharma hit by FDA ban on Gujarat plant, shares fall

Sun Pharma hit by FDA ban on Gujarat plant, shares fall

Rediff.com13 Mar 2014

Recently, Ranbaxy and Wockhardt too were hauled up.

Govt in talks with Pfizer, J&J for supply of vaccines to India

Govt in talks with Pfizer, J&J for supply of vaccines to India

Rediff.com2 Jun 2021

The central government is importing COVID-19 vaccines and is in talks with COVID-19 vaccine manufacturers Pfizer and Johnson & Johnson, Union Minister of State for Home Affairs G Kishan Reddy said.

Reddy's files with US FDA for generic Olanzapine

Reddy's files with US FDA for generic Olanzapine

Rediff.com11 Mar 2003

Drugmaker Dr Reddy's Laboratories has filed an application with the US Food and Drug Administration to market a generic form of Eli Lilly's schizophrenia drug Olanzapine in the US

HC raps Pepsico over use of stale ingredients

HC raps Pepsico over use of stale ingredients

Rediff.com31 Aug 2010

Joint Commissioner, Food and Drugs Administration, Pune, had suspended license for its for plants at Ranjangaon and Taregaon after an inspection in May 2009 found that company was using some ingredients which were past their "best before" date.

FDA raises concern over US unit: Wockhardt

FDA raises concern over US unit: Wockhardt

Rediff.com28 May 2014

Wockhardt MD Murtaza Khorakiwala said his firm had responded to the FDA's observations but declined to give details.

Cipla gets nod to import Moderna vaccine for emergency use in India

Cipla gets nod to import Moderna vaccine for emergency use in India

Rediff.com29 Jun 2021

India's drug regulator Drugs Controller General of India has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.

Sun Pharma's Halol facility listed under USFDA import alert

Sun Pharma's Halol facility listed under USFDA import alert

Rediff.com8 Dec 2022

Sun Pharmaceutical Industries Ltd on Thursday said its Halol facility in Gujarat has been listed under import alert by the USFDA with products manufactured at the unit now are subject to refusal of admission in the US market. The development follows an inspection of the facility by the US Food and Drug Administration (USFDA) from April 26 to May 9, 2022. "We now wish to inform you that the company has received a communication from the USFDA stating that the facility has been listed under Import Alert," Sun Pharma said in a regulatory filing.

3 Indian pharma cos recall products in US market

3 Indian pharma cos recall products in US market

Rediff.com24 Apr 2022

Leading drug firms Aurobindo Pharma, Sun Pharma and Jubilant are recalling different products in the US market for various reasons, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Aurobindo Pharma is recalling Cyanocobalamin Injection, which is used to treat and prevent lack of vitamin B12, Mumbai-based Sun Pharma is recalling a drug used to increase the production of natural tears in eyes. Similarly, Jubilant Cadista is recalling a drug which is used to treat different inflammatory conditions.

Reddy's eyes US launches this year

Reddy's eyes US launches this year

Rediff.com3 Jun 2003

Indian drugmaker Dr Reddy's Laboratories hopes to launch two-to-three generic products in the United States this year in a bid to increase its share of a lucrative market, its chief executive said.

Obama inks landmark anti-tobacco law

Obama inks landmark anti-tobacco law

Rediff.com23 Jun 2009

The law bans fruit and spice-flavoured cigarettes, slaps expansive new warnings on packages and gets rid of the monikers 'light' and 'low-tar'.

US authorizes Pfizer's COVID vaccine for emergency use

US authorizes Pfizer's COVID vaccine for emergency use

Rediff.com12 Dec 2020

According to The New York Times, this move means that many highly vulnerable people will begin receiving the vaccine within days. It further called the authorisation by the FDA as a 'historic turning point' as the US death toll from the Wuhan-originated virus nears 300,000.

Silicone breast implants may rupture: US FDA

Silicone breast implants may rupture: US FDA

Rediff.com8 Apr 2005

The alternative, saline implants, rupture too, but such failures are quickly recognised by women as their breasts deflate.

Pharma crusader takes India's drug regulators to court

Pharma crusader takes India's drug regulators to court

Rediff.com7 Mar 2016

Dinesh Thakur is famous for exposing Ranbaxy safety problems

Maggi trouble mounts for Nestle; Uttarakhand to test samples

Maggi trouble mounts for Nestle; Uttarakhand to test samples

Rediff.com31 May 2015

In fresh troubles for Nestle over safety standards of its famous Maggi noodle brand, the Uttrakhand Food Safety Department has collected samples of the 'two-minute' noodles from the company's Pantanagar plant and other places in the state.