US FDA issues CRL to Hikma’s generic version of GSK’s Advair Diskus
Hikma Pharmaceuticals has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for the abbreviated new drug application (ANDA) of its generic version of GlaxoSmithKline's Advair Diskus (fluticasone propionate and salmeterol inhalation powder).
The FDA has categorised the CRL as 'major', giving Hikma very low chances of approval this year.
The company is currently reviewing the response and will provide an update on its application after discussion with the FDA.
Following this setback, the company also witnessed a steep fall in its shares dropping by 8.95%, cityam.com reported.
The delay in the approval is expected to provide relief to GlaxoSmithKline’s Advair to avoid generic competition in the US market, reported Reuters.
Hikma and its partner Vectura were seeking approval to introduce a generic copy of Advair.
Previously, pharmaceutical company Mylan also applied for the generic version of the same drug, which is yet to be approved by the FDA.
Hikma claimed that no material issues were raised regarding the substitutability of the proposed medicine.
It also stated its commitment to bring this important product to the US market and collaborate with the FDA to resolve the outstanding issues.
Hikma's fluticasone propionate and salmeterol inhalation powder is designed for asthma treatment, decrease airflow obstruction and reduce exacerbations in patients affected with the chronic obstructive pulmonary disease.
The medicine is developed using Vectura's proprietary dry powder inhaler and formulation technology.