Abstral® Receives Japan’s MHLW Approval
News Sep 24, 2013
Recipharm Stockholm has announced that the company was informed on September 20, 2013 by the R&D-based pharmaceutical company, Kyowa Hakko Kirin Co. Ltd. (Tokyo, Japan, President and CEO: Nobuo Hanai, “Kyowa Hakko Kirin”) that Abstral® sublingual tablet (nonproprietary name: fentanyl citrate; referred to below as “Abstral®”), has been approved for manufacturing and marketing by Japan's Ministry of Health, Labour and Welfare(MHLW).
The approval allows Recipharm to carry out commercial scale manufacturing and packaging of Abstral® for supply to the Japanese market through Kyowa Hakko Kirin.
The drug product, Abstral® is a novel, highly potent, rapid disintegration, sublingual (under the tongue) formulation of fentanyl citrate.
This well-established opioid is used extensively for fast relief and management of episodes of breakthrough pain experienced by cancer patients that are already in receipt of opioid analgesics for cancer pain.
Japanese regulatory agency assessed Recipharm’s suitability through detailed analysis of the company’s history, capabilities, proven track record and the reliability of the supply chain set to take the product through to Japan, together with a thorough review of all clinical data and product documentation.
Recipharm will compress and formulate Abstral® in tablet dosage at its manufacturing site in Årsta, with all packaging performed at the company’s Jordbro complex. Quality control will be initiated in laboratories located in central Stockholm.
Thomas Beck, Director of Quality and Qualified Person at Recipharm Stockholm commented: “We are delighted to receive Japan’s MHLW approval to carry out a combination of both the manufacturing and the packaging of such a product, for onward supply to the Japanese market. Indeed, we are pleased, both because securing such authorization from a regulatory body outside of the EU is an extremely complicated process, especially in the case of Japan, and due to the fact that Abstral® is a highly innovative drug that enables fast relief of pain endured by patients undergoing cancer treatment.”
Shedding Light on How Tumors Become Resistant to ImmunotherapyNews
Researchers have now found that in skin cutaneous melanoma an epigenetic control protein is key to the development of immunotherapy resistance.READ MORE
Ingestible Drug-Delivery Materials May Improve Patient Treatment ComplianceNews
Hydrogel-based capsules could expand and reside in the GI tract for days, slowly releasing medication.READ MORE
Nanoparticle Delivery of Curcumin Induces Tumor Cell DeathNews
Attaching curcumin, a component of the common spice turmeric, to nanoparticles can be used to target and destroy treatment-resistant neuroblastoma tumor cellsREAD MORE
Comments | 0 ADD COMMENT
International Conference and Exhibition on Nanomedicine and Nanotechnology
Nov 23 - Nov 24, 2017