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 […]
Kindeva Drug Delivery
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 Aeolus dry-powder inhaler (DPI) platform technology, according to a news release. Under the agreement, Kindeva will lead […]
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 U.S. patients, according to a news release. Albuterol sulfate is used to […]
FDA tentatively approves first generic version of Symbicort inhalation aerosol
Viatris (NSDQ:VTRS) and Kindeva Drug Delivery announced today that the FDA granted tentative approval of the first generic version of Symbicort. Symbicort, an inhalation aerosol is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD). The drug had U.S. branded sales of $3.5 billion for the 12 months ended January 2021, according […]
Kindeva Drug Delivery launches as independent company from 3M
Kindeva Drug Delivery recently announced that it launched as an independent company, shedding its former 3M Drug Delivery Systems name. The formation of the independent company follows its acquisition by Altaris Capital Partners in a transaction that was worth $650 million. Through the acquisition, 3M will hold a 17% minority interest in Kindeva with Altaris. […]
