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Hikma Resumes Launch Of Advair Rival

Follows FDA Approval Of ANDA Amendment That Forced Pause

Executive Summary

Hikma has restarted launch activities for its generic version of GSK’s Advair respiratory blockbuster in the US, after the FDA gave the go-ahead following approval of an ANDA amendment.

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Despite turnover dropping by over a fifth in its financial third quarter, Lannett says it is optimistic that respiratory generics and insulins will offer the firm “durable” opportunities in future. The company has also just reorganized its finances to extend its debt maturity by four years, pushing it back past some of its key launches.

Advair Relaunch And Nasal Naloxone Nod Raise Hikma’s Expectations

Fresh from resuming launch of its generic version of Advair in the US, Hikma has also been boosted by an FDA approval for its 505(b)(2) naloxone 8mg nasal spray. Both developments are expected to drive the firm’s generics business to the top end of its guidance for 2021, management revealed.

Lannett Files ANDA For US Advair Rival

Lannett has become the latest company to file an ANDA for a generic rival to GSK’s Advair Diskus in the US. Meanwhile, the company has revealed that it is also exploring further respiratory opportunities.

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