us seeks injunction on indian drug firm ranbaxy
Last Updated : GMT 23:48:09
Arab Today, arab today
Arab Today, arab today

US seeks injunction on Indian drug firm Ranbaxy

Arab Today, arab today

Arab Today, arab today US seeks injunction on Indian drug firm Ranbaxy

Washington - AFP

US officials sought a \"groundbreaking\" injunction against Indian drug giant Ranbaxy, saying the maker of the first generic version of cholesterol-lowering Lipitor has failed to meet US safety guidelines. The filing, which would require Ranbaxy to stop selling drugs made at four of its manufacturing plants until it remedies deviations from current good manufacturing practices, could trigger multi-million-dollar repercussions as Ranbaxy\'s drug had been one of the most hotly anticipated rollouts of a generic when it hit the US market late last year. The Justice Department, citing manufacturing and data integrity shortcomings, on Wednesday said that US food safety authorities want to block the company from doing business here because its actions made \"many of Ranbaxy\'s drugs adulterated, potentially unsafe and illegal to sell in the United States.\" The US Food and Drug Administration (FDA) gave the Indian firm the go-ahead last November to make a generic version of Lipitor, which was the best-selling drug of all time and earned US pharma giant Pfizer $100 billion after coming on the market in 1997. Pfizer\'s patent on Lipitor -- atorvastatin calcium -- expired at the end of November. Ranbaxy, which is majority owned by Japan\'s Daiichi, had faced delays in gaining FDA approval due to problems with quality control at some of its Indian and US factories. Those problems came into sharp focus Wednesday with the department\'s filing, made at the request of the FDA, against India\'s Ranbaxy Laboratories -- and its US subsidiary Ranbaxy Inc -- in US District Court outside the capital Washington. \"This action against Ranbaxy is groundbreaking in its international reach,\" Tony West, assistant attorney general for the Justice Department\'s Civil Division, said in a statement. \"It requires the company to make fundamental changes to its plants in both the United States and India,\" he added. \"Our commitment to ensuring that the drugs the American people rely on are safe, effective and manufactured according to the FDA\'s standards extends beyond our borders.\" If and when the decree is approved by the court, \"it becomes a court order with which Ranbaxy must comply or face contempt,\" the Justice Department said. The Justice Department listed several problems, including \"inadequate testing of drugs to ensure that they kept their strength and effectiveness until their expiration date.\" In addition, \"Ranbaxy submitted false data in drug applications to the FDA, including the backdating of tests and the submitting of test data for which no test samples existed,\" it added. According to the consent decree, Ranbaxy must hire a third party expert to conduct an internal review at the facilities; implement procedures and controls to ensure data integrity; and withdraw any applications found to contain untrue statements or data irregularities that could affect application approval. In a separate statement, FDA said it took action to protect consumers. \"This company continued to violate current good manufacturing practice regulations and falsify information on drug applications,\" said Dara Corrigan, the FDA\'s associate commissioner for regulatory affairs. \"The FDA continues to be committed to protecting consumers from potentially unsafe products that may be offered on the market.\" It said notably that Ranbaxy\'s drugs would be barred from the US market as well as inclusion in the US President\'s Emergency Plan for AIDS Relief (PEPFAR) program \"until drugs can be manufactured at such facilities in compliance with US manufacturing quality standards.\" Ranbaxy said it had signed the consent decree in December ahead of the filing, and that the company was committed to strengthening procedures and policies. \"Separately, Ranbaxy also announced that it intends to make a provision of $500 million in connection with the investigation by the US Department of Justice, which the company believes will be sufficient to resolve all potential civil and criminal liability,\" it said. In the United States, anti-cholesterol drugs account for 255 million prescriptions a year, and about nine million people are taking Lipitor. US-based Watson Pharmaceuticals announced its launch of a generic version of Lipitor under an exclusive supply and distribution agreement with Pfizer, whereby Pfizer manufactures the drug and Watson sells it, sharing net sales with Pfizer until 2016. The FDA said it recommends that patients taking Ranbaxy-produced drugs maintain their drug therapy, but speak with their doctors.  

arabstoday
arabstoday

Name *

E-mail *

Comment Title*

Comment *

: Characters Left

Mandatory *

Terms of use

Publishing Terms: Not to offend the author, or to persons or sanctities or attacking religions or divine self. And stay away from sectarian and racial incitement and insults.

I agree with the Terms of Use

Security Code*

us seeks injunction on indian drug firm ranbaxy us seeks injunction on indian drug firm ranbaxy

 



Name *

E-mail *

Comment Title*

Comment *

: Characters Left

Mandatory *

Terms of use

Publishing Terms: Not to offend the author, or to persons or sanctities or attacking religions or divine self. And stay away from sectarian and racial incitement and insults.

I agree with the Terms of Use

Security Code*

us seeks injunction on indian drug firm ranbaxy us seeks injunction on indian drug firm ranbaxy

 



Arab Today, arab today
Arab Today, arab today Jordanian woman reveals her project

GMT 00:46 2017 Saturday ,11 November

Jordanian woman reveals her project
Arab Today, arab today Japanese regulators raid Airbnb

GMT 00:44 2017 Monday ,20 November

Japanese regulators raid Airbnb
Arab Today, arab today Keep kids busy at Thanksgiving gatherings

GMT 11:14 2017 Friday ,10 November

Keep kids busy at Thanksgiving gatherings
Arab Today, arab today Saudi, Bahrain target Iran

GMT 00:48 2017 Monday ,20 November

Saudi, Bahrain target Iran
Arab Today, arab today Europe turns on Facebook, Google

GMT 02:26 2017 Monday ,20 November

Europe turns on Facebook, Google
Arab Today, arab today
Arab Today, arab today
Arab Today, arab today Australian academic's book pulled

GMT 15:20 2017 Monday ,13 November

Australian academic's book pulled
Arab Today, arab today May under Brexit pressure at EU reform summit

GMT 02:14 2017 Saturday ,18 November

May under Brexit pressure at EU reform summit
Arab Today, arab today Delhi half-marathon to go ahead

GMT 03:51 2017 Saturday ,18 November

Delhi half-marathon to go ahead
Arab Today, arab today The history of solar eclipses

GMT 05:16 2017 Sunday ,20 August

The history of solar eclipses
Arab Today, arab today Driverless, electric future just round

GMT 02:45 2017 Monday ,20 November

Driverless, electric future just round
Arab Today, arab today Tesla unveils its all-electric semi truck

GMT 02:59 2017 Saturday ,18 November

Tesla unveils its all-electric semi truck
Arab Today, arab today Mona Abdel Ghany increased artistic activities

GMT 12:15 2017 Friday ,17 November

Mona Abdel Ghany increased artistic activities
Arab Today, arab today paObama climate envoy slams Trump's rejection

GMT 16:04 2017 Friday ,17 November

paObama climate envoy slams Trump's rejection

GMT 12:22 2017 Thursday ,16 November

Hanan Metawe denies apology for “Major Treason”

GMT 11:15 2017 Thursday ,16 November

Angola oil boss sacked by father's protege

GMT 18:41 2017 Friday ,20 October

Designer Aql Faqih aspires to innovation

GMT 11:38 2017 Wednesday ,15 November

Unloved vultures fight for their survival

GMT 11:49 2017 Thursday ,17 August

Egyptian artist presents new collection of designs

GMT 02:28 2017 Saturday ,18 November

Anti-drug operation nets 4 tonnes

GMT 01:34 2017 Friday ,17 November

Banyan Tree Phuket Takes Festive Season

GMT 17:12 2017 Monday ,07 August

Al-Shawaifi reveals secrets of total solar eclipse

GMT 16:53 2017 Tuesday ,05 September

Youssra depended on colored foam
Arab Today, arab today
Arab Today, arab today
 
 Arab Today Facebook,arab today facebook  Arab Today Twitter,arab today twitter Arab Today Rss,arab today rss  Arab Today Youtube,arab today youtube  Arab Today Youtube,arab today youtube
arabstoday arabstoday arabstoday arabstoday
arabstoday arabstoday arabstoday
arabstoday
بناية النخيل - رأس النبع _ خلف السفارة الفرنسية _بيروت - لبنان
arabstoday, Arabstoday, Arabstoday