HYDERABAD: Drugmaker Dr. Reddys Laboratories has launched Bortezomib for injection 3.5 mg/vial in the US market making use of a new drug application approval pathway, .
A cancer drug has been approved by the US Food and Drug Administration (USFDA) via a 505(b)(2) new drug application (NDA) pathway, the Hyderabad-headquartered pharma major said on Wednesday.
Bortezomib for injection is indicated for the treatment of adult patients with multiple myeloma and for the treatment of mantle cell lymphoma who have received at least one prior therapy.
This is a great addition to Dr. Reddys injectable offering in the US market as it continues to augment its portfolio of products in the hospital segment, Marc Kikuchi, CEO-North America Generics said. Customers and patients will benefit from this cost efficient alternative in the market place, he said in a release.
According to USFDA, applications approved under Section 505(b)(2) are those that contain full reports of investigations of safety and effectiveness. But where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.