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Hikma Offers Update On Plans For Advair Rival

Targets Launch In ‘Early 2021’ As Firm Provides Trading Update

 
• By Dave Wallace

Hikma has provided a trading update that sheds fresh light on plans for its delayed Advair generic, as well as revealing some new launches.

2020/1
Hikma’s planned generic Advair launch has been put back to 2021 • Source: Shutterstock

Hikma is planning to introduce its US generic version of GlaxoSmithKline’s Advair Diskus (fluticasone/salmeterol) early next year, the firm has outlined as it provided a trading update that offered revised financial forecasts as well as details of two new US generic launches.

In September, Hikma revealed that it had received a further complete response letter from the US Food and Drug Administration over its generic Advair abbreviated new drug application, albeit one characterized as minor. The firm said it was “working closely with the FDA to quickly address the small number of questions raised in the CRL,” adding that “once answered, Hikma can expect to receive a response from the FDA within 90 days

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