Mylan gains marketing authorization for TOBI Podhaler and TOBI Solution

22 July 2019

Following a positive opinion from the Committee on Human Medicinal Products (CHMP), the European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have granted the marketing authorization transfer to Netherlands-headquartered drugmaker Mylan (Nasdaq: MYL) for TOBI Podhaler and TOBI Solution in the UK for patients with cystic fibrosis.

Mylan acquired rights to the products from Novartis (NOVN: VX), which offloaded its cystic fibrosis portfolio to Mylan in a $463 million deal announced in September last year.

Mylan received final pan-European approval through a centralized procedure for the transfer of TOBI Podhaler (tobramycin inhalation powder, 28mg per capsule) on June 28, 2019, and nationally for TOBI Solution (tobramycin, 300mg/5ml for nebulization) on June 5, 2019.

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