Zydus Lifesciences wins USFDA nod to manufacture Lidocaine, Prilocaine Cream

Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Lidocaine and Prilocaine Cream USP, 2.5%/2.5% (USRLD: EMLA Cream, 2.5%/2.5%).

Lidocaine and Prilocaine Cream USP is indicated as a topical anaesthetic for use on normal intact skin for local analgesia and genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anaesthesia.

Lidocaine and Prilocaine cream will be produced at the Group’s topical manufacturing site at Changodar, Ahmedabad.

Lidocaine and Prilocaine cream had annual sales of USD 22.05 mn in the United States (IQVIA MAT October 2024). The group now has 412 approvals and has so far filed over 473* ANDAs since the commencement of the filing process in FY 2003-04.

Medical Dialogues team earlier reported that the company had received approval from the Subject Expert Committee SEC, which is functional under the Central Drug Standard Control Organisation (CDSCO) for a phase IV study to evaluate the safety of Pertuzumab (Sigrima, Zydus Lifesciences Limited) in patients with HER2-positive metastatic and early breast cancer. Pertuzumab is an antineoplastic agent used in the treatment of HER2-positive metastatic breast cancer in combination with other antineoplastic agents. Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). It consists of two heavy chains and two lights chains that have 448 and 214 residues respectively.

Read also: Zydus Lifscience Gets CDSCO Panel Nod To study Anti-cancer Drug Pertuzumab