Case Study: USFDA approval of Exeltis’s Slynd, an oral contraceptive tablet
Exeltis USA, Inc. a division of the global pharmaceutical group Insud Pharma, announced that the US Food and Drug Administration (FDA) has... Read More
USFDA accepted triple drug FDC empagliflozin, linagliptin and metformin extended release (XR) for the treatment of adults with type 2 diabetes
Posted on06 Jun 2019
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Boehringer Ingelheim and Eli Lilly and Company announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application... Read More
Luye Pharma’s Rykindo NDA Filing Accepted by the US FDA
Rykindo, Luye Pharma’s innovative, independently developed Extended-Release Microspheres formulation for injection, is one step closer to going on the U.S. market. The... Read More
What is USFDA – Field Alert Report (FAR) Submission for NDAs and ANDAs?
Posted on31 Jul 2018
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FAR – Field Alert Report Submission FAR should be submitted using Form FDA 3331a. This is for applicants of new drug applications... Read More