Mumbai: Drug maker Aurobindo Pharma Ltd said it has received tentative approval from the US Food and Drug Administration (FDA) to sell antidepressant escitalopram oxalate in tablet form. The approval is for 5, 10 and 20mg strengths of the drug, which is the generic version of Forest Laboratories Inc.’s Lexapro, Aurobindo said in a statement. Lexapro generated about $2.6 billion (Rs13,494 crore today) in sales for the 12 months ending September, Aurobindo added.
EU, developing states clash over drug swoop
Geneva: The European Union (EU) and developing countries clashed on Tuesday over the treatment of generic drugs, with Brazil accusing Brussels of trying to undermine special public health rules for poor countries.
But the EU said it had the right to inspect generic drugs in transit, to protect its citizens and people in developing countries from the risk of fake medicine.
The argument involved the detention in December by Dutch customs authorities of an Indian generic drug to treat high blood pressure while in transit in the Netherlands for Brazil.
It touches on one of the most sensitive issues between rich and poor countries—access to affordable medicine—and has been cited by developing countries as an example of rising protectionism in the economic crisis.
Australian regulator also probes Ranbaxy
Sydney: Australian health regulator Therapeutic Goods Administration is investigating Indian pharmaceutical company Ranbaxy Laboratories Ltd, following US allegations of the company falsifying data and test results of new drug applications, a media report says.
“The administration is investigating the latest allegations against the Ranbaxy plant but has withheld further action against the company insisting that previous Australian checks cleared the plant,” the ‘Sydney Morning Herald’ has reported.
A Ranbaxy spokesperson declined to comment on the report.