Monday, 20 May 2019

Strides gets USFDA nod for Lidocaine Ointment

19 December 2018 | News

Lidocaine Ointment contains a local anesthetic agent which is administered topically to numb and relieve pain from minor burns, skin abrasions, and other painful conditions affecting mucous membranes

Strides Pharma Science Limited (Strides) has announced that it step down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval forLidocaine Ointment USP 5% from the United States Food & Drug Administration (US FDA). Lidocaine Ointment is a generic version of Xylocaine® Ointment of AstraZeneca Pharmaceuticals LP.

Lidocaine Ointment contains a local anesthetic agent which is administered topically to numb and relieve pain from minor burns, skin abrasions, and other painful conditions affecting mucous membranes.  Lidocaine Ointment is also used to numb the skin before certain medical procedures.

According to IQVIA MAT data, the US market for Lidocaine Ointment USP 5% is approximately $ 50million.  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 the date and 26 are pending approval.

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