Drug Approval | February 14, 2022
Zydus gets 180 days of shared exclusivity for Roflumilast tablets
The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad
The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad
Arformoterol Tartrate had estimated annual sales of US $ 251 million in the U.S. (IQVIA MAT December 2021)
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India registers 18% of deaths annually due to air pollution while seven million die annually across the world due to air pollution
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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