The Center for Drug Evaluation has issued a notification concerning the Chemical Generic Drug Reference Preparation Adjustment List, inviting public feedback on the draft proposal before the deadline of October 7, 2023. The list proposes the removal of Ambroxol inhalable solution and four other varieties, totaling nine specifications.
Specific Drugs Affected by the Proposal
The drugs set to be removed include Sanofi’s (EPA: SAN) Eloxatin (injectable oxaliplatin), Kissei Pharma’s Xanbon (injectable ozagrel), Maruishi Pharma/Ono Pharma’s (TYO: 4528) Cataclot and Xanbon (ozagrel injection), Sanofi’s Mucosolvan (ambroxol inhalable solution), and GSK’s (NYSE: GSK) Ventolin (inhalable salbutamol solution).
Reasons for Removal
Injectable oxaliplatin is recommended for terminal sterilization, and its current dosage form is deemed unreasonable, warranting removal. Injectable Ozagel has been flagged for removal due to the irrationality of the current reference formulation. Ambroxol inhalable solution and inhalable salbutamol solution are proposed for removal because they do not meet the Chinese Pharmacopoeia’s requirements for inhalation preparations, which mandate that “inhalation liquid preparations should be sterile.”
Historical Context and Impact
The Notice on Chemical Generic Drug Reference Preparation Adjustment Procedures, released by the National Medical Products Administration (NMPA) in March this year, provides context for this draft proposal. Since the initiation of reference preparation selection in 2016, a total of 66 batches of such drugs have been released, encompassing 2408 varieties or 6174 specifications. The proposed adjustments reflect ongoing efforts to ensure the safety and efficacy of drugs included in the reference list.-Fineline Info & Tech
