Cipla Ltd shares have gained as much as 16 per cent after the company received approval from the US Food and Drug Administration (USFDA) for its generic version of Proventil HFA Inhalation Aerosol drug.
At 10.45 am, the stock traded at Rs 585.60, up 14.15 per cent from its previous close, while the benchmark Sensex rose 2.93 per cent and BSE Healthcare index advanced 4.74 per cent.
In an exchange filing, Cipla said it has received ‘final approval for its abbreviated new drug application (ANDA) for Albuterol Sulfate Inhalation Aerosol 90mcg (base)/actuation from the USFDA.’ The drug is the first AB-rated generic therapeutic equivalent version of Merck Sharp & Dohme Corp’s Proventil HFA Inhalation Aerosol. It is used to treat acute episodes of bronchospasm or prevention of asthmatic symptoms. According to IQVIA (IMS Health), Proventil and its authorised generic equivalent had sales of approximately $153 million in the US for the 12 months ended February 2020.
The entire Albuterol Sulfate HFA Inhalation Aerosol market had US sales of approximately $2.8 billion during the same period. ‘We are pleased to receive the final approval for generic Albuterol MDI from the USFDA. This further strengthens our presence in the US market. 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,’ said Umang Vohra, managing director and chief executive officer (MD & CEO), Cipla.
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