Zydus Lifesciences bags USFDA nod for Plerixafor Injection

Ahmedabad: Zydus Lifesciences Limited has announced that the company has received final approval from the United States Food and Drug Administration (USFDA) for Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), Single-Dose Vial (USRLD: Mozobil Injection, 24 mg/1.2 mL [20 mg/mL]).

Plerixafor is used by patients with certain types of cancer (non-Hodgkin's lymphoma-NHL, multiple myeloma-MM) to prepare them for stem cell transplant.

The drug will be manufactured at the group’s injectable manufacturing facility of Zydus Lifesciences Ltd. (Alidac) at SEZ, Ahmedabad (India).

Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), Single-Dose Vial had annual sales of USD 210 mn in the United States (IQVIA MAT May 2023). The group now has 374 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.

Medical Dialogues team had earlier reported that the company had received tentative approval from the USFDA for Palbociclib tablets, which are available in 75 mg, 100 mg, and 125 mg strengths. Palbociclib is used to treat a certain type of breast cancer and its works by slowing or stopping the growth of cancer cells.

Read also: Zydus Lifesciences gets tentative nod from USFDA for Palbociclib tablets

Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian Pharmaceutical company headquartered in Ahmedabad. The Company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals. It is primarily engaged in the manufacture of generic drugs.