by inpharmedia | Jul 24, 2023 | Blog
Every product should have a sufficient level of quality to ensure its efficacy and safety. The impurities/degradation products are the ones that arise during different stages of synthesis, manufacture and storage. They should be controlled at certain level to maintain... by inpharmedia | Feb 3, 2023 | Approvals, Blog, Regulatory
The U.S Food and Drug Administration (USFDA) has approved 04 new drugs in the month of January. Out of the 04 approvals, 03 are NDA and 01 is BLA. LEQEMBI ITEMDESCRIPTIONNDA/BLA Number:761269Applicant/Holder:EISAI INCAPI:LecanemabDosage... by inpharmedia | Dec 19, 2021 | Blog
The Hatch-Waxman Act provides certain market exclusivities for new drug applicants based on two factors: Patent Non-patent The patent related exclusivities are part of the discussion and we will learn further in this article. PATENT EXCLUSIVITY & the ORANGE BOOK:... by inpharmedia | Aug 15, 2021 | Blog
Exclusivity: Exclusivity is exclusive marketing rights granted by the Health Authority upon approval of a novel drug molecules and can run concurrently with a patent or not. It prevents the submission or effective approval of generic applications and was designed to... by inpharmedia | Apr 27, 2021 | Blog
Every new drug must prove to be safe and effective to be approved by any health authorities. The new drug/therapeutic moieties invented are protected by a specific patent that allows the innovator firm or patent holder to enjoy the exclusivity to market the product... by inpharmedia | Jan 9, 2021 | Blog
An RTR decision indicates that FDA determined that an ANDA is not substantially complete. A substantially complete ANDA is “an ANDA that on its face is sufficiently complete to permit a substantive review“. It identifies certain deficiencies and certain recurrent...