News for 'US Food & Drug Administration'

Wockhardt receives US nod for cardiac drug

Wockhardt receives US nod for cardiac drug

Rediff.com23 Jul 2010

Pharmaceutical and biotechnology major, Wockhardt has received final approval from the United States Food & Drug Administration for marketing the cardiac drug.

Cipla HIV drug gets USFDA nod

Cipla HIV drug gets USFDA nod

Rediff.com26 Jun 2006

Cipla has got tentative approval from the USFDA for its abbreviated new drug application for anti-HIV/AIDS drug Slamivudine.

Soaring cancer drug costs may cripple medicare

Soaring cancer drug costs may cripple medicare

Rediff.com29 Jan 2009

A new report says laws crimp Medicare's ability to control costs on cancer, leading to a 267% increase in drug spending over seven years

Indian firms eye $2.5-bn US drug market

Indian firms eye $2.5-bn US drug market

Rediff.com28 Apr 2011

The anti-depressant drug market in the US is primarily ruled by Effexor XR (Venlafaxine) of Wyeth (now owned by Pfizer).

Lupin receives US FDA nod for drug

Lupin receives US FDA nod for drug

Rediff.com28 Jul 2003

Lupin Ltd received US Food & Drug Administration's approval for its abbreviated new drug application for Cefuroxime Axetil tablets.

Dr Reddy's launch generic cancer drug in US market

Dr Reddy's launch generic cancer drug in US market

Rediff.com12 Jul 2013

The company has launched the Decitabine for injection in the strength of 50 mg in the US market following approval by the United States Food & Drug Administration of Dr Reddy's abbreviated new drug applications, it said in a statement.

Dr Reddy's launches insomnia drug in US; Glenmark gets FDA nod

Dr Reddy's launches insomnia drug in US; Glenmark gets FDA nod

Rediff.com16 Apr 2014

Sunovion Pharmaceuticals Inc is the owner of the Eszopiclone drug.

Wockhardt gets USFDA nod for anti-depressant tablets

Wockhardt gets USFDA nod for anti-depressant tablets

Rediff.com3 Sep 2012

The company said it is launching the product immediately

Dr Reddy's launch generic version of Xyzal in US

Dr Reddy's launch generic version of Xyzal in US

Rediff.com28 Mar 2011

Hyderabad, Mar 28 (PTI) Dr Reddy's Laboratories Limited has launched Levocetirizine tablets (5mg), a bio-equivalent generic version of Xyzal tablets in the USA market, the company said on Monday.

Maharashtra asks Snapdeal to stop selling prescription drugs

Maharashtra asks Snapdeal to stop selling prescription drugs

Rediff.com18 Apr 2015

Flipkart, Amazon, too, under radar

Ranbaxy gets FDA nod for Fluconazole tablets

Ranbaxy gets FDA nod for Fluconazole tablets

Rediff.com6 May 2003

Ranbaxy Laboratories has received tentative approval form the Food & Drug Administration USA for manufacturing and marketing Fluconazole tablets

Why Daiichi is taking Malvinder Singh to court

Why Daiichi is taking Malvinder Singh to court

Rediff.com27 Nov 2013

The Japanese company alleges the earlier Ranbaxy promoters withheld crucial information when they sold the company in 2008.

Wockhardt to launch new antibiotic in US next week

Wockhardt to launch new antibiotic in US next week

Rediff.com2 Jun 2006

The company has already received approval from the US Food & Drug Administration for marketing clarithromycin tablets.

Dr Reddy's launches generic Parkinson's disease tablets in US

Dr Reddy's launches generic Parkinson's disease tablets in US

Rediff.com7 Jun 2012

The tablets are bio equivalent generic version of GlaxoSmithKline's Requip XL tablets

Parle knocks on Bombay HC doors over Mango Bite

Parle knocks on Bombay HC doors over Mango Bite

Rediff.com17 Oct 2012

On Oct 14, the Maharashtra unit of FDA had ordered recall of entire stock of Kachha Mango Bite from the marketplace.

Wockhardt antibiotic gets USFDA nod

Wockhardt antibiotic gets USFDA nod

Rediff.com1 Jun 2006

Wockhardt Ltd said on Thursday it has received approval from USFDA for marketing antibiotic, Clarithromycin tablets, in the US market.

Wockhardt gets US nod for Zonisamide

Wockhardt gets US nod for Zonisamide

Rediff.com26 Dec 2005

Wockhardt has received United States Food & Drug Administration approval to market Zonisamide capsules.

Lupin inks pact with Allergan in US

Lupin inks pact with Allergan in US

Rediff.com29 Mar 2004

Lupin Pharmaceuticals Inc, a wholly owned subsidiary of Mumbai-based Lupin Ltd, has forayed into the US pediatric segment by inking an agreement with Allergan Inc to promote 'Zymar' in that country.

FSSAI launches probe into MDH and Everest products

FSSAI launches probe into MDH and Everest products

Rediff.com23 Apr 2024

The Food Safety and Standards Authority of India (FSSAI) has commissioned a quality check on MDH and Everest products. This follows complaints that several popular spice mixes of the two leading brands contained traces of ethylene oxide more than the permissible levels, official sources said. This move by FSSAI comes after Hong Kong and Singapore recalled variants of the two masala majors' products in their countries.

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

US regulator tightens drug approval norms

US regulator tightens drug approval norms

Rediff.com29 Jul 2013

Companies asked to give data for three batches instead of one; move may lead to significant rise in development cost of generics

Aurobindo Pharma gets nod for AIDS tablets

Aurobindo Pharma gets nod for AIDS tablets

Rediff.com28 Jun 2013

The company has received the tentative approval from the US Food & Drug Administration to manufacture and market these combination tablets in strengths of 600mg/300mg/ 300mg, a statement by Aurobindo Pharma said.

US FDA conducts surprise inspection of Dr Reddy's Vizag plant

US FDA conducts surprise inspection of Dr Reddy's Vizag plant

Rediff.com20 Nov 2014

The FDA has been tightening its monitoring of Indian pharma majors over compliance issues. Surprise plant inspections and import alerts have been frequent outcomes

Nestle once again in court over 'sub-standard' Maggi

Nestle once again in court over 'sub-standard' Maggi

Rediff.com30 Mar 2016

In Uttar Pradesh, standards for 'Macaroni products' are being applied for 'Instant Noodles with seasoning' which is erroneous and misleading, alleges Nestle.

Crocin Quick gives GSK a headache

Crocin Quick gives GSK a headache

Rediff.com27 Sep 2005

Pfizer Covid vaccine gets US experts' nod

Pfizer Covid vaccine gets US experts' nod

Rediff.com11 Dec 2020

The Pfizer vaccine has already been approved for the public in the United Kingdom and, Canada.

Investors concerned about Wockhardt

Investors concerned about Wockhardt

Rediff.com17 Oct 2013

The rap from both the US and UK drug regulators, including the latest one from the latter, has hit the scrip.

As Maggi goes off menu, Nestle gears up for damage control

As Maggi goes off menu, Nestle gears up for damage control

Rediff.com28 May 2015

The central government has said it will look into the matter.

Piramal Enterprises to stop early-stage research

Piramal Enterprises to stop early-stage research

Rediff.com28 Aug 2014

To focus on molecules at advanced stage of development; move to impact 200 scientists.

Why train travel will never be the same again

Why train travel will never be the same again

Rediff.com14 Jul 2020

The first two coaches that rolled out from the Railway Coach Factory in Kapurthala also have fixtures coated with titanium dioxide and the provision for plasma air equipment in AC ducts to sterilise interiors using ionised air. Railway Minister Piyush Goyal also indicated that the new coaches could be the new normal.

What is ailing India's pharma sector?

What is ailing India's pharma sector?

Rediff.com18 Aug 2016

Low growth visibility and trouble with regulators have resulted in lack of interest from investors

Nestl comes up with 'miss-you Maggi' ads

Nestl comes up with 'miss-you Maggi' ads

Rediff.com26 Aug 2015

The under-one-minute films are titled 'Menu Cards, Mom and Neighbours'.

Now, US FDA gets a call from Indian pharma companies

Now, US FDA gets a call from Indian pharma companies

Rediff.com27 Oct 2013

The Indian Pharmaceutical Alliance has approached regulator for a dialogue to understand the concern raised by it

Maggi ban: Regulator overreach, says Nestle counsel

Maggi ban: Regulator overreach, says Nestle counsel

Rediff.com21 Jul 2015

Nestle India has been arguing that ban order was arbitrary.

Sensex gains on Fed rally; posts best week since mid-June

Sensex gains on Fed rally; posts best week since mid-June

Rediff.com9 Oct 2015

Sensex, Nifty put up a good show in closing trade.

Pharma stocks could rise another 15-20%

Pharma stocks could rise another 15-20%

Rediff.com28 Jul 2014

Expectations of strong results, consistent performance and investors preference for stocks in the defensive space help the sector outshine broader markets.

Samvat 2072: Auto sector could see faster recovery

Samvat 2072: Auto sector could see faster recovery

Rediff.com11 Nov 2015

Samvat 2072: Auto sector could see faster recovery