Dr Reddy's Laboratories Limited on Wednesday announced the launch of Bortezomib for injection in the US market. The drug is indicated for the treatment of adult patients with multiple myeloma or with mantle cell lymphoma who have received at least one prior therapy.
Bortezomib is an active ingredient similar to that of the once blockbuster cancer treatment Velcade of Millennium Pharmaceuticals, a subsidiary of Takeda Pharmaceutical Industries, and Johnson & Johnson.
"We are pleased to bring this product to market for the customers and patients who will benefit from this cost efficient alternative in the market place," said Marc Kikuchi, chief executive officer, North America Generics, at Dr Reddy's. "This is a great addition to our injectable offering in the US market as we continue to augment our portfolio of products in the hospital segment."
Dr Reddy's product was approved by the US Food and Drug Administration (USFDA) via 505(b)(2) new drug application, one of the drug approval pathways that partly depend on the previous studies related to its safety and efficacy.