Strides Pharma Science Limited
(Strides) announced that its step‐down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Lidocaine Ointment USP 5% from the United States Food & Drug Administration (USFDA). Lidocaine Ointment is a generic version of Xylocaine Ointment of AstraZeneca Pharmaceuticals LP.
According to IQVIA MAT data, the US market for Lidocaine Ointment USP 5% is approximately US$50mn. The product will be marketed by Strides Pharma Inc. in the US market and will be launched immediately. The company has 80 cumulative ANDA filings with USFDA of which 54 ANDAs have been approved as of date and 26 are pending approval.