22nd Sep 2020 08:48
(Alliance News) - Hikma Pharmaceuticals PLC said Tuesday it has been given a "minor" complete response letter by the US Food & Drug Administration, relating to its new drug application for its own version of the Advair Diskus inhaler.
The US regulator sends a complete response letter if it decides to not approve the application in its present form.
Advair Diskus, originally a GlaxoSmithKline PLC product, treats asthma and chronic obstructive pulmonary disease.
Hikma said it is working to address the questions raised in the letter, and once answered expects to receive a response within 90 days. The group now expects to gain approval for its generic version in early 2021.
As a result, Generic revenue for 2020 is expected to be between USD710 million to USD730 million, compared to the USD719 million the year before. In addition, Generics core operating margin is set to be ranged from 18% to 19%.
Shares in Hikma Pharmaceuticals were down 4.1% at 2,479.00 pence on Tuesday in London.
By Dayo Laniyan; [email protected]
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