Teligent reports FDA approval of ANDA for topical anaesthetic
2 July 2018 -

The US Food and Drug Administration (FDA) has approved Teligent Inc's (NASDAQ:TLGT) abbreviated new drug application (ANDA) for Lidocaine and Prilocaine Cream USP, 2.5%/2.5%, a topical anaesthetic, the pharmaceutical company announced on Monday.

This is Teligent's seventh approval so far this year, and the 26th approval from its internally developed pipeline of topical generic pharmaceutical medicines.

IQVIA data from April 2018 suggests that the total addressable market for this product is approximately USD44m.

The company plans to launch the product in the US market in the third quarter of 2018.

Teligent now has 31 topical generic pharmaceutical products in its US portfolio, in addition to its four US injectable products.