Company as forfeited its eligibility for 180-day exclusivity for its ANDA
Drug firm Ranbaxy Laboratories on Thursday said the US health regulator has revoked its tentative approvals for its generic anti-viral drug and stomach and esophagus problems treatment tablets
New Delhi: Drug firm Ranbaxy Laboratories on Thursday said the US health regulator has revoked its tentative approvals for its generic anti-viral drug and stomach and esophagus problems treatment tablets.“As a consequence, in FDA’s view, Ranbaxy has forfeited its eligibility for 180-day exclusivity for its ANDA for valganciclovir hydrochloride tablets USP, 450 mg,” Ranbaxy Laboratories said in a filing to BSE. The communication from USFDA said that Ranbaxy’s ANDAs of concern did not have any data integrity issues.
However it added that “its original decisions granting tentative approvals were in error because of the compliance status of the facilities referenced in the ANDAs at the time the tentative approvals were granted.”In another developement, Competition Commission is likely to finalse this month its decision on the $4 billion Sun Pharma-Ranbaxy deal — the first M&A transaction to have gone through public scrutiny amid concerns of adverse impact on fair competition in the market.
The big-ticket deal, which would create the country’s largest pharmaceutical company, has come under close scrutiny of CCI after it was found prima-facie that the “combination is likely to have an appreciable adverse effect on competition”.
( Source : PTI )
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