Drug Approval | November 23, 2021
U.S. FDA approves Alembic’s Formoterol Fumarate inhalation solution
The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
The agreement sharpens the company’s focus on priority medicines in respiratory & immunology portfolio
It is one of the first companies to launch a bioequivalent version of the dry powder inhaler and it's part of the company’s strategic exclusive in-licensing arrangement to market Tiotropium DPI in Western Europe and the UK
It is the first branded generic alternative to Fostair 100/6 pMDI
The financing secures funds to advance the clinical development of EpiEndo’s lead compound EP395, which entered phase I clinical trials in April, through Phase IIa, targeting COPD as a primary indication
Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL is AN-rated generic therapeutic equivalent version of Sunovion Pharmaceuticals Inc.’s Brovana
Arformoterol Tartrate Inhalation Solution is for treatment of bronchoconstriction
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