Hikma says it has now addressed all outstanding questions from the US Food and Drug Administration over the firm’s application for a generic version of GlaxoSmithKline’s Advair Diskus (fluticasone/salmeterol) blockbuster respiratory brand.
Hikma Addresses Advair Issues In US
Responds To All Outstanding Questions In The FDA’s CRL
Hikma has submitted a response to the US FDA addressing all outstanding deficiencies in its application for a generic version of GlaxoSmithKline’s Advair Diskus.

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Meitheal Pharmaceuticals said that its generic version of the GLP-1 agonist Victoza would be one of 22 planned launches during 2025, as the firm continues to build out its portfolio with the aid of its parent, Hong Kong King-Friend Industrial.
A UK High Court justice came down on the side of Glenmark in AstraZeneca’s bid to enjoin the firm from launching a generic version of its Forxiga blockbuster before judgment is delivered in the firms’ patent-litigation clash.