Cipla shines on getting USFDA nod for ANDA

Cipla Limited has received a final approval for its abbreviated new drug application (ANDA) for Albuterol Sulfate Inhalation Aerosol 90 mcg (base)/actuation from United States Food and Drug Administration (USFDA).

Cipla’s Albuterol Sulfate Inhalation Aerosol 90 mcg (base)/actuation, is the first AB-rated generic therapeutic equivalent version of Merck Sharp & Dohme Corp’s Proventil HFA Inhalation Aerosol. It is used for the treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms.

As per the data of IQVIA (IMS Health), Proventil HFA Inhalation Aerosol and its authorised generic equivalent had US sales of approximately $153 million for 12-month period ending February 2020. The entire Albuterol Sulfate HFA Inhalation Aerosol market had US sales of approximately $2.8 billion for 12-month period, ending February 2020.

Albuterol is the first generic metered dose inhaler of Proventil HFA Inhalation Aerosol ever approved by FDA in US as well as Cipla’s first device-based inhalation product in the market.

Cipla is a global pharmaceutical company having complex generics and deepening portfolio in the markets of India, South Africa, North America and key regulated & emerging markets. It is engaged in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments.

On Thursday, the stock of Cipla jumped by ~16 per cent to Rs 595 from its previous close of Rs 513 on BSE.