Ranbaxy loses 6-month exclusivity for generic drug to US dirty tricks
7 Nov 2014 10:41 PM GMT
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 US Food and Drug Administration (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.’
FDA has rescinded the previously granted tentative approvals for Ranbaxy's ANDAs for esomeprazole magnesium delayed-release capsules, 20 mg and 40 mg and for valganciclovir hydrochloride tablets USP, 450 mg, Ranbaxy Laboratories said. ‘Ranbaxy is disappointed with this development and is actively evaluating all available options to preserve its rights,’ the company said.
Meanwhile, the Competition Commission of India (CCI) 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’.
The Competition Commission of India, which is mandated to keep a tab on unfair trade practices in the market place across sectors, is expected to take a final decision on the Sun Pharma-Ranbaxy deal this month, a senior official said.
The public scrutiny of the deal, which would create the fifth largest specialty generics company in the world, ended on 24 September. Major issues being examined by CCI on the deal are with respect to the molecules market.
The combined entity would have operations in 65 countries, 47 manufacturing facilities across 5 continents, and a significant platform of specialty and generic products marketed globally. The deal, announced in April this year, is also the first one where the CCI sought public comments.
The Competition Commission of India had on 4 September said that the comments should be submitted to it within 15 working days. They were to be submitted along with supporting documents on the way the merger can adversely impact the person or the entity concerned.
The communication from US Food and Drug Administration (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.’
FDA has rescinded the previously granted tentative approvals for Ranbaxy's ANDAs for esomeprazole magnesium delayed-release capsules, 20 mg and 40 mg and for valganciclovir hydrochloride tablets USP, 450 mg, Ranbaxy Laboratories said. ‘Ranbaxy is disappointed with this development and is actively evaluating all available options to preserve its rights,’ the company said.
Meanwhile, the Competition Commission of India (CCI) 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’.
The Competition Commission of India, which is mandated to keep a tab on unfair trade practices in the market place across sectors, is expected to take a final decision on the Sun Pharma-Ranbaxy deal this month, a senior official said.
The public scrutiny of the deal, which would create the fifth largest specialty generics company in the world, ended on 24 September. Major issues being examined by CCI on the deal are with respect to the molecules market.
The combined entity would have operations in 65 countries, 47 manufacturing facilities across 5 continents, and a significant platform of specialty and generic products marketed globally. The deal, announced in April this year, is also the first one where the CCI sought public comments.
The Competition Commission of India had on 4 September said that the comments should be submitted to it within 15 working days. They were to be submitted along with supporting documents on the way the merger can adversely impact the person or the entity concerned.
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