 "Ranbaxy files lawsuit against US FDA's Valcyte and Nexium rulings")
Ranbaxy has filed a lawsuit in the District of Columbia in the US against the decision of US Food & Drug Administration (US FDA) to revoke the approvals for the generic versions of Valcyte (marketed by Roche) and Nexium (marketed by Astrazenca).
In the first week of November, the Gurgaon-based drug maker announced that US FDA has withdrawn the previously granted tentative approvals for Ranbaxy’s ANDAs for esomeprazole magnesium (Nexium) delayed-release capsules, 20 mg and 40 mg and for valganciclovir hydrochloride (Valcyte) tablets USP, 450 mg because of the compliance status of the facilities referenced in the ANDAs at the time the tentative approvals were granted. As a consequence, in US FDA’s view, Ranbaxy has forfeited its eligibility for 180-day exclusivity for its ANDA for valganciclovir hydrochloride tablets USP, 450 mg. After this, US FDA granted Dr Reddy's Laboratories and US-based Endo International Plc the approval for making generic version of Valcyte.
At that time, Ranbaxy had said that it was disappointed with this development and was actively evaluating all available options to preserve its rights.
Ranbaxy filed the lawsuit on November 11, 2014 and has named Sylvia Mathews Burwell, Secretary of Health and Human Services; Margaret Hamburg, Commissioner of US FDA, and US FDA in it.
In the lawsuit, Ranbaxy has stressed that the agency (US FDA) issued its decision with no prior notice to Ranbaxy. It also claimed that the US FDA had no power to issue its decision - which not only rescinds decisions FDA made over six years ago after it carefully considered all of the relevant facts, but hinges on a putative interpretation of the Federal Food, Drug, and Cosmetic Act (FDCA) that is impossible to square with the statute’s plain text and structure.
Some experts believe that loss of six-month exclusivity period for two drugs (Valcyte and Nexium) in the US market could cost Ranbaxy as much as $200 million in revenue.
In the first week of November, the Gurgaon-based drug maker announced that US FDA has withdrawn the previously granted tentative approvals for Ranbaxy’s ANDAs for esomeprazole magnesium (Nexium) delayed-release capsules, 20 mg and 40 mg and for valganciclovir hydrochloride (Valcyte) tablets USP, 450 mg because of the compliance status of the facilities referenced in the ANDAs at the time the tentative approvals were granted. As a consequence, in US FDA’s view, Ranbaxy has forfeited its eligibility for 180-day exclusivity for its ANDA for valganciclovir hydrochloride tablets USP, 450 mg. After this, US FDA granted Dr Reddy's Laboratories and US-based Endo International Plc the approval for making generic version of Valcyte.
At that time, Ranbaxy had said that it was disappointed with this development and was actively evaluating all available options to preserve its rights.
Ranbaxy filed the lawsuit on November 11, 2014 and has named Sylvia Mathews Burwell, Secretary of Health and Human Services; Margaret Hamburg, Commissioner of US FDA, and US FDA in it.
In the lawsuit, Ranbaxy has stressed that the agency (US FDA) issued its decision with no prior notice to Ranbaxy. It also claimed that the US FDA had no power to issue its decision - which not only rescinds decisions FDA made over six years ago after it carefully considered all of the relevant facts, but hinges on a putative interpretation of the Federal Food, Drug, and Cosmetic Act (FDCA) that is impossible to square with the statute’s plain text and structure.
Some experts believe that loss of six-month exclusivity period for two drugs (Valcyte and Nexium) in the US market could cost Ranbaxy as much as $200 million in revenue.