FDA Approves Generic Skin Disorder Treatment

The FDA has approved Teligent Inc’s abbreviated new drug application for desoximetasone ointment USP 0.25%, which is the generic equivalent of Taro Pharmaceuticals’ Topicort Ointment.

The market for this topical product, which is used to treat swelling and itching caused by skin disorders, is around $17 million, according to IMS Health data from December 2015.

Teligent submitted the abbreviated new drug application to the FDA back in November 2014.

"Teligent received FDA approval for desoximetasone ointment USP 0.25% in 15 months in a first cycle review, which is consistent with the FDA's goals under the Generic Drug User Fee Amendments (GDUFA),” said Jason Grenfell-Gardner, president and CEO of Teligent, in a press release. “This is our first product approved from our pipeline of applications filed under GDUFA Year 3, which began on October 1, 2014.”'

Teligent said it hopes to launch the ointment in 15 g, 60 g, and 100 g tubes in the second quarter of 2016.