{"id":7741,"date":"2024-10-18T14:44:57","date_gmt":"2024-10-18T06:44:57","guid":{"rendered":"https:\/\/flcube.com\/?p=7741"},"modified":"2024-10-18T14:47:34","modified_gmt":"2024-10-18T06:47:34","slug":"huahai-pharmaceutical-gets-fda-nod-for-generic-empagliflozin-and-metformin-anda","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=7741","title":{"rendered":"Huahai Pharmaceutical Gets FDA Nod for Generic Empagliflozin and Metformin ANDA"},"content":{"rendered":"\n

Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521<\/a>), 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\u2019s (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.<\/p>\n\n\n\n

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\u2019s empagliflozin and metformin expires. Until then, Huahai Pharma\u2019s 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.<\/p>\n\n\n\n

This development underscores Huahai Pharmaceutical\u2019s commitment to expanding its global footprint and enhancing access to quality, cost-effective medications for patients worldwide.- Flcube.com<\/a><\/p>\n\n\n\n

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Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a prominent Chinese pharmaceutical company, has announced the…<\/p>\n","protected":false},"author":1,"featured_media":7742,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[390,39,775,15,1381],"class_list":["post-7741","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-boehringer-ingelheim","tag-diabetes","tag-huahai-pharmaceutical","tag-product-approvals","tag-sha-600521"],"yoast_head":"\nHuahai Pharmaceutical Gets FDA Nod for Generic Empagliflozin and Metformin ANDA - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"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\u2019s (BI) empagliflozin and metformin combination therapy. 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