Regulatory nod gives Ranbaxy green light to launch its generic version of Novartis’ Diovan with 180-day exclusivity; other ANDA holders may continue to challenge Ranbaxy’s hold on the market.
FDA approved Ranbaxy Laboratories Ltd.’s ANDA for a generic version of Novartis AG’s blockbuster hypertension drug Diovan (valsartan) June 26, giving the company 180-day marketing exclusivity from the time of launch.
Ranbaxy said it would disclose launch plans for the long-delayed antihypertensive agent in a forthcoming press release.
Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.
The European Medicines Agency has OKd 10 new medicines for EU-wide approval, including a CAR-T therapy for treating acute lymphoblastic leukemia. Two drugs were, however, rejected.
