A.forall receives FDA OK for generic THAM Solution tromethamine injection

A.forall, Milla Pharmaceuticals has received the Food and Drug Administration’s blessing through its U.S. subsidiary for a generic version of Hospira's THAM Solution Tromethamine Injection 18GM/500ml.

This marks the sixth overall ANDA approval for A.forall and another instance where Competitive Generic Therapy eligibility has been granted. Moreover, Milla Pharmaceuticals is commercializing Tromethamine injection using their own label and their expanded U.S. market presence, offering more direct access to customers and patients, the company noted.

“As this product was previously reported in shortage in the U.S. for multiple years, the approval and launch of Tromethamine Injection reinforce our mission of making affordable medicines available to all, by continuing the expansion of high-quality generic injectables supply throughout and beyond the U.S. market,” said Erik Lazarich, A.forall’s president of U.S. Operations.

[Read more: Generic drug makers continue forging ahead]

Commercialization is currently underway, with a 180-day exclusivity as from launch.