Viatris, Kindeva win FDA approval for first generic version of Symbicort inhalation aerosol

Viatris (Nasdaq:VTRS) and Kindeva Drug Delivery announced today that the FDA approved its generic version of AstraZeneca’s Symbicort.

In March 2021, the FDA granted tentative approval to Breyna (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol) — the first generic version of Symbicort. Today, the agency granted approval for the abbreviated new drug application (ANDA) for the drug-device combination product for certain patients with asthma or chronic obstructive pulmonary disease (COPD).

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Kindeva, Cambridge Healthcare Innovations to collaborate on dry-powder inhaler

Kindeva Drug Delivery and Cambridge Healthcare Innovations announced a collaboration to commercialize the latter’s dry-powder inhaler.

St. Paul, Minn.-based Kindeva is set to use its product development, regulatory affairs and manufacturing capabilities to help develop and commercialize CHI’s αeolus dry-powder inhaler (DPI) platform technology, according to a news release.

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Sandoz announces in-licensing of Kindeva respiratory inhalation aerosol

Sandoz announced that it is in-licensing the commercial distribution rights to a respiratory inhalation medicine from Kindeva Drug Delivery.

Princeton, N.J.-based Sandoz in-licensed the rights to the brand and authorized generic of Proventil HFDA (albuterol sulfate) inhalation aerosol, which is immediately available to patients in the U.S., according to a news release.

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