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US generic approvals for Acrux and Cipla

Generics/News | Posted 16/07/2021 0 Post your comment

In late June 2021, Australian pharmaceutical company Acrux received United State Food and Drug Administration (FDA) approval to market its generic version of Vallant’s Jubila (efinaconazole). In addition, Indian generics maker Cipla received final FDA approval for a generic version of Sunovion Pharmaceuticals Inc’s Brovana, an arformoterol tartrate inhalation solution.

Acrux generic approval
Efinaconazole is a topical solution used to treat toenail fungus.

Acrux sought to release their generic product prior to the Jubila’s patent expirations in the US and filed an abbreviated new drug application for the product in 2018. As part of the settlement and following the US approval, the company is now negotiating with a commercial licensee to commercialize the product in the US.

Cipla generic approval
Arformoterol is a long-acting beta-2 adrenergic agonist (beta-2 agonist). The Brorvana originator is indicated for the long-term treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Cipla’s arformoterol tartrate inhalation solution will be available as 15 mcg/2 mL doses and is now available in the US. The new product hopes to tap into the Brovana market which achieved US sales of approximately US$438 million for the 12-month period ending April 2021, according to IQVIA (IMS Health) data.

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