Mylan (NASDAQ: MYL), a global pharmaceutical company, has voluntarily waived its exclusive rights to distribute its generic version of Kaletra (lopinavir/ritonavir) antiretroviral 100mg/25mg and 200mg/50mg tablets in the United States, it was reported on Wednesday.
This move is intended to help increase the available supply of the product should it prove effective in the treatment of coronavirus. It will allow the company to enable other generic applicants to be eligible for FDA approval of their medicines for patients in the United States, expanding access in the event that additional clinical studies or other evaluations conclude that the product may be effective in treating COVID-19.
The company was the first to file a substantially complete abbreviated new drug application with the Food and Drug Administration (FDA) to launch a generic version of this product to market, entitling the company to a 180-day marketing exclusivity period upon final FDA approval, which is pending.
Viatris names new chief legal officer
Alvotech signs biosimilar supply and commercialisation deals with Sandoz
InSysBio agrees new collaborative project with BeOne Medicines
MS Pharma enters strategic partnership with Hetero Group
Apiject to open new generic injectable drug manufacturing facility in Apex, NC
Bionpharma and STEERLife's Etravirine tablets approved by US FDA
ScinoPharm Taiwan secures first US FDA approval for complex multiple sclerosis generic
ScinoPharm Taiwan's Glatiramer Acetate Injection approved by US FDA
Accord Healthcare launches Clomiphene tablets in US market
Zentiva receives ESG Transparency Award 2025
Galmed Pharmaceuticals reports topline results for combination of Aramchol, Stivarga and metformin
Ingenus Pharmaceuticals' generic equivalent to Premarin receives US FDA approval
EirGenix signs second global exclusive licensing deal with Sandoz