FDA’s interpretation and application of the Best Pharmaceuticals for Children Act (“BPCA”), which provides for a 6-month add-on period of pediatric exclusivity has piqued our interest more than once over the years, leading to several posts (see, e.g., here, here, and here). We now have another interpretation to add to the collection
Accord Healthcare`s Ivabradine Receives Approval In Europe
Accord`s Ivabradine Receives Approval In Europe
Six new medicines, including three orphan drugs for rare diseases, have been backed for European Union approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
JensonR+ Limited Gets EU Nod For Ivabradine
Zentiva, k.s. Gets EU Nod For Ivabradine
Eleven new medicines have taken a giant leap closer to European Union approval after having won the backing of the Committee for Medicinal Products for Human Use.
On April 25, 2016, the Mumbai Patent Office’s Deputy Controller of Patents & Designs, N. Ramchander issued an order granting Cadila Healthcare Limited (Cadila or Company) Indian patent application (1966/MUM/2006) for a novel crystalline formulation of the cardiovascular drug Ivabradine Hydrochloride. According to publicly available information, at least six (6) other patents have been granted by the Indian Patent Office that cover Ivabradine HCl and eight (8) additional companies have pending patent applications for Ivabradine HCl before the Patent Office.
The objective of the current work was to develop Ivabradine hydrochloride (HCl) floating pulsatile pellets containing drug loaded calcium alginate pellets coated with pH-dependent polymer Eudragit S100 oil dispersion.
Anpharm`s Ivabradine approved in Europe for Coronary Artery Disease