Perrigo wins final US FDA approval for AB Rated generic Mycolog II Cream
17 August 2017 -

Healthcare company Perrigo Company plc (NYSE:PRGO) (TASE:PRGO) reported on Wednesday the receipt of final approval from the US Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing Mycolog II Cream (nystatin and triamcinolone acetonide cream USP, 100,000 units/gram and 1 mg/gram).

In the Q4 2017, the company is expected to introduce its AB Rated generic version of Mycolog II Cream in the commercial market in the US.

The company said the Mycolog II Cream is indicated for the treatment of cutaneous candidiasis.

For the 12 months ended June 2017, the annual market sales for Mycolog II Cream was approximately USD93m, according to the company.