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Sept. 22, 2020, 3:05 a.m. EDT

Hikma expects generic drug approval in early 2021

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By Joe Hoppe

Hikma Pharmaceuticals PLC said Tuesday that it has received a minor complete response letter from the U.S. Food and Drug Administration regarding its generic version of GlaxoSmithKline PLC's Advair Diskus, and that it now expects approval for the drug in early 2021.

The FTSE-100 pharmaceutical company said it will address the issues raised in the letter. Once Hikma addresses the issues in the letter, it expects an answer from the FDA within 90 days.

Hikma said that it now expects 2020 generics revenue to be in the range of $710 million to $730 million, and core operating margin to be in the range of 18% to 19%.

Write to Joe Hoppe at joseph.hoppe@wsj.com

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