Mylan and Micro Labs receive US FDA approval for two generic versions of Pfizer and BMS’ Eliquis, marking the first generic approvals of direct oral anticoagulants.
US FDA updates Mylan’s ANDA to commercialize a generic of Lilly’s Alimta with a tentative approval, putting the company on course to enter the market in 2022.
Mylan’s recently FDA-approved Advair Diskus generic to be offered at 70% cost reduction to its reference drug, and 67% less than GSK’s generic version.
Mylan has requested all lots of valsartan, as well as combination amlodipine/valsartan, and valsartan/ hydrochlorothiazide tablets, be returned in the US.
The decision, influenced by the expected loss of exclusivity for Restasis, will allow the company to ‘improve efficiencies’ across its manufacturing network, a spokesperson explained.
The US FDA has granted expiration date extensions for specific lots of Mylan’s EpiPen auto-injectors, as manufacturer Pfizer works to stabilise supply.
In a second quarter call with investors, president of Mylan, Rajiv Malik, stated the company has undertaken a restructuring and remediation plan at its Morgantown, West Virginia plant.
