FDA: Ranbaxy falsified data on drug applications

Daiichi Sankyo may be second guessing its $4.6 billion acquisition of Indian generics maker Ranbaxy. Just before Daiichi sealed the deal in November, federal regulators banned the importation of drugs from Ranbaxy's Paonta Sahib and Batamandi facilities. Now, the FDA has halted the review of all drug applications from the Paonta Sahib site. A year-long investigation uncovered falsified data of shelf-life tests and other measures on approved and pending applications for 25 of Ranbaxy's drugs, including cholesterol-lowering drugs, pravastatin (Pravachol) and imvastatin (simvastatin), and the antihistamine pheniramine (Avil), the agency said in a teleconference today.

Ranbaxy is India's largest generics company and one of the largest suppliers of generics to the US. All of the drugs for which data was falsified likely reached US markets, but due to the September import ban, newly manufactured drugs have not reached stores. Regulators said they have no evidence that the drugs on the market pose health risks and recommended that patients continue with their prescriptions. "We've not uncovered any harm associated with Ranbaxy products currently marketed in the U.S.," said FDA Deputy Director Douglas Throckmorton. "We feel comfortable leaving those products on the market at this time."

The FDA first accused Ranbaxy of fabricating data in July of 2008. In a motion filed in Maryland, the agency said it uncovered a "pattern of systematic fraudulent conduct," which resulted in generic drugs that contained the incorrect amount of active ingredients. But officials said that they have inspected Ranbaxy's other plants more than 20 times over the past four years and have not found similar problems at those facilities, the Associated Press reports.

The Hindustan Times reports that an unidentified spokesperson said that the company was surprised by the FDA actions and had no knowledge regarding the reasons for the FDA's search of their facilities today. "The company is not aware of any wrongdoing. It will co-operate fully with the officials."

- read Ranbaxy's release
[1]- check out the AP report [2]
- read the Hindustan Times report [3]
- view the US News and World Report take [4]

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Daiichi and Ranbaxy - Top 10 deals of 2008 [5]
To lift FDA ban, Ranbaxy may buy plants [6]
Ranbaxy waves white flag at Feds [7]
Ranbaxy investigation spins off new probes [8]
Feds say Ranbaxy faked data [9]
FDA halts Ranbaxy India imports [10]