Ranbaxy’s Valsartan ANDA Wins FDA Approval After Lengthy Delay
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
In a suit against FDA, Mylan argues that Ranbaxy’s delay in getting tentative approval for its valsartan ANDA within 30 months of submission triggered forfeiture of its 180-day marketing exclusivity.
FDA is worried about drug names that could appear to overstate efficacy and impact consumer and healthcare provider perceptions of the product.
Emergence of the inter partes review process dramatically changed the patent dispute arena. The decade also brought biosimilar litigation, generic price-fixing complaints, opioid lawsuits and new government investigations and antitrust actions.