FDA Accepts Hikma’s ANDA for Generic of GSK Respiratory DrugBy
Hikma Pharmaceuticals PLC reports that its abbreviated new drug application (ANDA) for fluticasone propionate and salmeterol inhalation powder has been accepted for filing by the US Food and Drurtg Administration (FDA). The product is the generic version of GlaxoSmithKline’s Advair Diskus, which is indicated for the treatment of asthma and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease and is delivered using Vectura's proprietary dry-powder inhaler and formulation technology.
The FDA provided Hikma, through its wholly owned subsidiary, West-Ward Pharmaceuticals, an action goal date of May 10, 2017.
Source: Hikma Pharmaceuticals