Japan’s key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…
REGULATORY
MHLW to Set AI Limit for Atomoxetine’s Nitrosamine Impurities at 100 ng/Day
Japan will set an acceptable intake (AI) limit of 100 ng per day for N-nitroso-atomoxetine, a potentially carcinogenic nitrosamine, for the ADHD drug atomoxetine after the substance was found in some of the API used in a product marketed by…
To read the full story
Related Article
- Strattera and All Generic Versions Now under Supply Restrictions in Japan
December 17, 2024
- All Versions of Lilly’s Strattera under Restricted Supplies in Japan
November 26, 2024
- Shipment Curbs Growing for Strattera Generics amid Nitrosamine Issues
November 18, 2024
- Lilly Japan Halts Manufacturing of Strattera over Nitrosamine Impurities
November 14, 2024
- Sawai Joins List of Atomoxetine Recalls after Establishing Test Model
September 27, 2024
- Don’t Stop Taking Atomoxetine at Own Discretion: MHLW to Patients
September 4, 2024
REGULATORY
- Japan Approves Zepbound, Qalsody, and Lots More Drugs
December 27, 2024
- Quality Assurance and Lag/Loss Fight to Form Pillars of PMD Act Amendment
December 27, 2024
- LDP Members Urge Ministers to End “Mechanical” Off-Year Price Cuts
December 27, 2024
- Japan to Set Up Fund to Spur Generic Shakeup; CEA, Market Expansion Re-Pricing on Agenda
December 26, 2024
- Gist of FY2025 Drug Price Revision
December 26, 2024
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
Takeda Pharmaceutical’s overseas sales ratio has reached 90.9%, exceeding 90% for the first time though only in the first half…
In a recent conversation with James Feliciano, former president of AbbVie Japan, we delved into the intricacies of leadership in the Japanese pharmaceutical industry. Feliciano, a seasoned industry veteran, shared valuable insights into his experiences, challenges, and successes.Navigating the Abbott…
A Japanese health ministry panel on November 28 agreed on a plan to legally require pharma companies to set up…
Eli Lilly’s Kisunla (donanemab) will join the Japanese reimbursement list on November 20, with a health ministry panel giving the…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…