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    Home > Medical News > Medical World News > Analysis of the development course of Agaquban injection

    Analysis of the development course of Agaquban injection

    • Last Update: 2020-05-13
    • Source: Internet
    • Author: User
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    The author of theexplains the development process of Agaquban injections in Japan and the United States, and analyzes the key knowledge points involved in the pharmaceutical research and development process for sharing and learning exchangesTable 1 Agaquban Injection Approval
    Table 2 The main development history in Japan(1) Takeda Pinya Co., Ltd., Fusan ProductS Co., Ltd., Nipro Co., Ltdand Japanese Medical Engineering Co., Ltdcarried out the imitation development of the Agaquban injection 20ml: 10mg specifications, respectivelyHowever, the development time is later than that of Sakai Pharmaceuticals(2) three adaptations associated with HIT were designated as orphan drugs as early as March 2004(3) about the small specification 2ml:10mg Agaquban injection developed by Mitsubishi Tianbian, with a core composition patentPatent noJP3781308, Chinese tongs 200480007612.8, patent name is containing fine aminomine pharmaceutical preparations, expiration date is March 19, 2024's Agaquban injection specifications are 20ml:10mg, and its development process is for generics to be marketedAt present, the website of Sai Pharmaceuticals can be retrieved its first product for SlonnonHI Note 10mg/2mL/NovastanHI Note 10mg/2mLThe chemical generic reference preparation catalogue (26th batch) is mentioned in the draft for comments, in the non-approved reference formulation varieties catalog, Agaquban injection 20ml: 10mg specifications given the conclusion sitford by the consistency evaluation expert committee, this product for the modification of the specification sylbi, has been issued the original research import for the reference preparation, the original research did not have this specification's Agaquban injection 20ml:10mg specification (listed in July 2001) was listed before the 2ml:10mg specification (July 2005) of Mitsubishi Inai PharmaceuticalCo, via time logicWhen the Agaquban injection from Yai Pharmaceuticals was marketed, it should be copied from the 20ml:10mg preparation first developed by Tamabian Mitsubishi (June 1999), which was discontinued in March 2006 after being replaced by a 2ml:10mg specification In October 2019, The 20ml:10mg specification of the Agaquban injection by Yujing Pharmaceuticals was compared with the Standard Product of The Mitsubishi 2ml:10mg specification thus, Agaquban injection 20ml: 10mg specification reference preparation, combined with our consistency evaluation policy, (1) Agarquban injection of Sakai Pharmaceutical has confirmed the first product for 2 ml specifications of the injection, the variety need to be treated according to the specifications? (2) If the variety in accordance with the idea of consistency evaluation, The original research specifications of Tamabian Mitsubishi have been discontinued, Agarquban injection of Acura pharmaceutical is listed in Japan according to the process of generic drugs, then the varieties of Yanjing Pharmaceuticals can not obtain the legal status of the reference preparations? can (3) refer to FDA guidelines, refer to DraftGuidancefor Industry: Referencing ApprovedDrugProductSinASubmissions.FDACDER, 2017, to confirm a clear Aagaquban injection of 20ml: 10mg specifications of the reference preparation? (4) as a generic drug, if the development of 20 ml: 10 mg specifications of Agaquban injection, Yujing Pharmaceutical 20ml: 10mg and Tianbian Mitsubishi 2ml: 10mg specifications of the injection in the imitation process how to use it? 1, Agaquban small-capacity injection market history
    Table 3 Agaquban small-capacity injection in the United States market (1) prescription to reduce the amount of ethanol in the United States, Pfizer first developed 100 mg/ml of Agaquban injection, due to the high content of waterless ethanol in the prescription, HIKMAPHARM and FRESENIUSKAUSA company to carry out follow-up 505b (2) of the development of non-prescription ethanol, the development of non-prescription alcohol at the same time (2) Patent Challenge success story
    patent US5214052 protects a agaquandinin in ethanol, water and sugar compositions, HIKKMAPANDand and FRESENIUSKABIUSA followed up with the development of 505b (2), successfully replacing sugars with propylene glycol excipients, while also meeting effective clinical safety and efficacy Table 4 Agaquban high-capacity injection stos (1) NDA (022485) approval process, compared with RLD Pfizer NDA (020883), after diluting to the same concentration, there is no water-free ethanol supplement in the prescription composition The in vitro pharmacodynamic activity (aPTT, PT and TT) of this product is similar to the activity of an RLD product, which is delivered in the same way, dosage and indications as RLD products (2) NDA (022434) approval process, the auxiliary lactose acid through in vitro hemolytic and animal tests to determine its safety The in vitro pharmacodynamic activity (aPTT, PT and TT) of this product is similar to the activity of RLD products, in the formulation contains L-methionine USP, lactose acid does not cause safety problems, the product's route of administration, dosage form and indications are the same as RLD products (3) NDA (203049) approval process, this product obtained a temporary approval As a result of the approval of the 2012-1-5 high concentration of NDA (203049) and clinical use through the dilution of different types of injectable solute, the company eventually developed the Agaquban high-capacity injection using sodium chloride injection as a professional so-based vector and was approved for market release in 2016-9-30 (4) NDA (206769) approval, this product is the NDA (022485) equidistant ratio, from 125ml isometric amplification to 250 ml, and thus approved, so the FDA did not give the symbol RLD status During the development process of Mitsubishi Tanaka, Japan, the size was reduced by one-tenth from 20ml:10mg to 2ml:10mg, and protected by the composition patent And for China's development of 20 ml:10 mg specifications of the reference preparation confirmation left suspense Pfizer developed high concentrations of Agaquer in the U.S., and subsequent companies have developed the injection in a 505b(2) manner HiKMAPHARM and FRESENIUSKAUSA's small-capacity injection challenge disenfranchised US5214052 through 505b (2) and were successful HIKMAPHARM also received temporary approval for high-volume injections original title: Agaquban Injection Development Process, What's The Thought sedating for us
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