Cipla surges 15% on USFDA nod for first generic Proventil HFA inhaler

Proventil HFA (albuterol sulfate) metered-dose inhaler is used for the treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms.

Shares of Cipla were locked in the upper circuit of 15 per cent at Rs 590, also its 52-week high on the BSE on Thursday after the drug firm received United States Food and Drug Administration's (USFDA)  nod for the first generic Proventil HFA (albuterol sulfate) metered dose inhaler, used for conditions such as asthma.

Till 09:29 am, a combined 1.79 million shares traded and there were pending buy orders for 744,000 shares on the NSE and BSE, the exchange data shows. Cipla is trading in future and option (F&O) segment and the F&O stocks don't have any circuit limit.

“The company has received final approval for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol 90mcg (base)/actuation, from the USFDA,” Cipla said in its press release today.

This 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, it added.

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

Albuterol is the first generic metered dose inhaler of Proventil HFA Inhalation Aerosol ever approved by FDA in the US and Cipla’s first device-based inhalation product in the market, the management said. The company is planning shipments in a staggered manner.