US Food and Drug Administration

Dr Reddy's continues to see huge selling, down over 5%

The stock has fallen by over 20 percent in three days.

 

Nov 10, 2015, 13:14 PM IST

Pocket-sized device to warn of asthma attacks

The device is a sensor that works with a companion app to accurately measure two important lung functions: FEV1 (how much air you can exhale in one second) and Peak Flow (how fast you can exhale).

Oct 29, 2015, 17:45 PM IST

Novartis gets USFDA warning letter for two plants in India

Sandoz, the generic drug arm of Swiss drug major Novartis, has received a warning letter from the US health regulator for violations of current good manufacturing practice (cGMP) norms at its two plants in Western India.

Oct 28, 2015, 21:05 PM IST

Aurobindo may launch Tramadol tablets in US market

Aurobindo Pharma has rreceived final approval from the US Food and Drug Administration to launch Tramadol Hydrochloride extended-release tablets in the US maket.

Oct 23, 2015, 13:28 PM IST

US launches anti-smoking campaign targeting 'hip-hop' teens

'Fresh Empire' is part of the FDA's ongoing efforts to combat tobacco uptake and use among youth.

Oct 07, 2015, 20:23 PM IST

FDA approves immunotherapy drug to fight lung cancer

The US Food and Drug Administration (FDA) on Friday approved the drug Keytruda to treat the most common form of lung cancer.

Oct 05, 2015, 13:06 PM IST

Low radiation during CT scan can lower cancer chances

Low radiation during computed tomography (CT) scans can reduce the chances of cancer in patients undergoing treatment, doctors here said on Thursday.

Oct 01, 2015, 22:04 PM IST

Sun Pharma says USFDA denies approval to sell epilepsy drug

India`s Sun Pharma Advanced Research Company Ltd (SPARC) said the U.S. Food and Drug Administration has denied its application for approval to launch a new anti-epilepsy drug, citing manufacturing quality issues at its production site.  

Sep 26, 2015, 12:36 PM IST

Wockhardt recalls over 1.62 lakh cartons of drugs in US

As per the information available on the US Food and Drug Administration's (USFDA) website, Mumbai-based Wockhardt is recalling the drugs for current good manufacturing practice (CGMP) deviations.

Jul 16, 2015, 19:05 PM IST

Dr Reddy's Laboratories working on 18 new drug applications

Drugmaker Dr Reddy's Laboratories Limited is working on 18 new drug applications, including the three NDAs it has already filed with the US Food and Drug Administration, and expects 2 more drugs to go for approvals before 2018.

Jun 21, 2015, 21:32 PM IST

'Pharma industry grappling with pricing, regulatory issues'

The buoyant pharmaceutical industry is still struggling to deal with the challenges around pricing in the domestic market, increased regulations as well as data integrity, says an EY survey.

Jun 03, 2015, 21:12 PM IST

IPCA Labs aims to make plants US FDA-compliant by December

IPCA Laboratories Ltd is aiming to make all of its plants facing import alerts from the United States compliant with U.S. Food and Drug Administration (FDA) rules by December, an executive said on Wednesday.

Mar 25, 2015, 13:51 PM IST

IPCA slumps as FDA bans imports from 2 more plants

Shares in generic drugmaker IPCA Laboratories slumped as much 12.7 percent, heading towards their biggest daily fall since July 2014, after the U.S. Food and Drug Administration (FDA) issued an import alert against two of its plants.

Mar 25, 2015, 13:18 PM IST

Micro Labs recalls 54,096 bottles of cholesterol drug in US

Micro Labs is voluntarily recalling 54,096 bottles of Simvastatin Tablets, a drug for lowering cholesterol, in the US market for failing to meet specifications.

Mar 19, 2015, 18:09 PM IST

US FDA Commissioner Margaret Hamburg to step down

Dr. Margaret Hamburg, who as commissioner of the US Food and Drug Administration (FDA) for almost six years has overseen public health initiatives ranging from tobacco control and food safety to personalized medicine and drug approvals, is stepping down, the agency said on Thursday.

Feb 06, 2015, 02:53 AM IST

USFDA to increase its India headcount

The US Food and Drug Administration (FDA), which has offices in New Delhi and Mumbai, is in the process of increasing its headcount in India to 19.

Feb 04, 2015, 17:13 PM IST

Cadila recalls 19,536 bottles of cough treatment drug in US

Drug firm Cadila Healthcare is voluntarily recalling 19,536 bottles of benzonatate capsules, used to treat coughs, in the US due to "wet and/or leaking capsules".

Jan 08, 2015, 19:46 PM IST

USFDA issues warning letter to Cadila Pharmaceuticals

The US Food and Drug Administration (USFDA) has issued a warning letter to Ahmedabad-based Cadila Pharmaceuticals for violating current good manufacturing practice norms at its Ankleshwar plant in Gujarat.

Nov 12, 2014, 17:50 PM IST