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FDA withdraws nod to 27 Ranbaxy ANDAs

Thursday, 23 August 2012 - 8:45am IST | Place: Mumbai | Agency: dna

The US Food and Drug Administration has withdrawn approval given to 27 generic products of Ranbaxy Laboratories.

The US Food and Drug Administration has withdrawn approval given to 27 generic products of Ranbaxy Laboratories.

In a letter posted on its website, the regulator said Ranbaxy had requested for withdrawal of approval to 27 of its abbreviated new drug applications (ANDAs) under a consent decree it entered in January this year.

The 27 drugs include certain antibiotic capsules and oral suspensions, and drugs for fungal infection and diabetes,.

A Ranbaxy spokesperson said these products do not pertain to the current business of the company and hence will have negligible impact.

“The company feels that certain products with negligible commercial impact should be withdrawn to enable the organisation to focus on other applications that are of greater importance to the US business,” said the spokesperson.

An analyst, who did not wish to be named, said such a move has to do with the compliance issues. “Ranbaxy might be first wanting to solve its problems with the FDA over the Dewas and Paonta Sahib plants before launching new products.”

An expert from an advisory firm said the company would focus on its money-spinning opportunities such as generic Actos and Lipitor, instead of products of negligible value.

The Gurgaon-based company raked in over $600 million on generic Lipitor during the exclusivity period, which ended on May 29.

In a conference call with analysts following the June quarter results, CEO and MD Arun Sawhney said the company enjoyed a share of about 55% on generic Lipitor during the six-month exclusivity. “Now in the post-exclusivity period, we still have a share of about 40%.”

Sawhney had said the company capitalised and successfully monetised the exclusivity opportunity.

Similarly, Ranbaxy, which enjoys the authorised generic status on diabetes drug Actos along with Israeli firm Teva, launched its generic version last week.

Analysts expect the company to earn about $180-200 million during the six-month exclusivity on this drug, which once had sales of $2.6-2.7 billion.

“Considering Teva is also in the fray, $180-200 million for Ranbaxy on generic Actos is a reasonable take,” said the analyst.

Ranbaxy had entered into a consent decree with US FDA to resolve its long pending issues related to the drug regulator blacklisting its manufacturing plants in Dewas and Paonta Sahib.

In the consent decree, Ranbaxy said it was committed to strengthen procedures and policies and comply with current good manufacturing practices.

The US FDA, in September 2008, had banned Ranbaxy from exporting drugs from Dewas and Paonta Sahib on quality issues and had stopped marketing approvals for new ones.

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