AstraZeneca-Ranbaxy drug settlement not anti-competitive
In a landmark judgement for pharma sector, a US jury has ruled that AstraZeneca's patent litigation settlement for blockbuster drug Nexium with Ranbaxy was not anti-competitive.
Dec 06, 2014, 22:57 PM IST
Dr Reddy's plant gets USFDA fiat on suspected lapses
The company is in the process of responding to the FDA's observations, a Dr Reddy's spokesperson said.
Nov 26, 2014, 19:44 PM IST
Ranbaxy sues USFDA for revoking approval to sell 2 drugs
Ranbaxy Laboratories has sued USFDA over revoking an approval to sell generic versions of two drugs -- digestive disorder medicine Nexium and anti-viral Valcyte-- in the US market.
Nov 18, 2014, 20:00 PM IST
Ranbaxy sues FDA over revoking approvals for Nexium, Valcyte copies
Ranbaxy Laboratories Ltd has sued the U.S. Food and Drug Administration (FDA) for revoking approvals granted to the firm to launch copies of two drugs including AstraZeneca Plc`s heartburn pill Nexium, court documents showed.
Nov 18, 2014, 15:35 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
Ranbaxy loses 6 months exclusivity for generic antiviral drug
Drug firm Ranbaxy Laboratories today said the US health regulator has revoked its tentative approvals for its generic anti-viral drug and stomach and esophagus problems treatment tablets.
Nov 06, 2014, 20:12 PM IST
Lupin gets USFDA nod for arthritis drug
Drug firm Lupin Tuesday said it has received approval from the US health regulator to market generic version of GD Searle LLC's Celebrex capsules, used to treat arthritis, in the American market.
Nov 03, 2014, 17:18 PM IST
Aurobindo gets USFDA nod to market generic anti-infective drug
Aurobindo now has a total of 195 ANDA approvals from the USFDA.
Sep 16, 2014, 17:10 PM IST
Wockhardt drug discovery gets fast track approval by USFDA
This is the first instance of an Indian pharmaceutical company receiving a QIDP status, Wockhardt said in a release issued here.
Sep 01, 2014, 08:16 AM IST
USFDA grants QIDP status to two Wockhardt drugs
Drug maker Wockhardt on Sunday said that two of its anti-infective drugs have received Qualified Infectious Disease Product (QIDP) status from the US health regulator.
Aug 31, 2014, 19:08 PM IST
Sun Pharma unit recalls mutiple lots of capsules from US
Caraco Pharmaceutical Laboratories , a unit of Sun Pharma, has initiated a recall of multiple lots of Cephalexin capsules from the US market.
Aug 15, 2014, 11:15 AM IST
Ranbaxy gets FDA approval for Novartis' Diovan generic
Ranbaxy will be the first rival drugmaker to launch a copy of Diovan in the United States and will be entitled to six months of exclusivity to sell it.
Jun 27, 2014, 09:39 AM IST
Dr Reddy's launches generic Paricalcitol capsules in US market
Drug firm Dr Reddy's Laboratories has launched generic Paricalcitol capsules used for treating secondary hyperparathyroidism associated with chronic kidney disease in the American market, following approval by the US health regulator.
Jun 25, 2014, 13:32 PM IST
USFDA cites Apotex's Bangalore drug facility for fraudulent data
The inspection found that the company routinely completed sample analyses and recorded the data only if the results were acceptable.
Jun 18, 2014, 09:38 AM IST
