Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a prominent Chinese pharmaceutical company, has announced the receipt of Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its generic version of Boehringer Ingelheim’s (BI) empagliflozin and metformin combination therapy. This therapy was originally approved in the US for the treatment of type 2 diabetes in August 2015 and remains under patent protection.
The ANDA approval is a significant milestone for Huahai Pharmaceutical, positioning the company to potentially enter the US market with a generic alternative once the patent for Boehringer Ingelheim’s empagliflozin and metformin expires. Until then, Huahai Pharma’s copycat product cannot be marketed in the US, but the ANDA approval brings the company one step closer to offering a more affordable option for patients with type 2 diabetes once the FDA grants the final approval post-patent expiration.
This development underscores Huahai Pharmaceutical’s commitment to expanding its global footprint and enhancing access to quality, cost-effective medications for patients worldwide.- Flcube.com
