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    Home > Medical News > Medical World News > Qilu pharmaceutical "pregabalin capsule" will be approved as the first one to pass the consistency evaluation

    Qilu pharmaceutical "pregabalin capsule" will be approved as the first one to pass the consistency evaluation

    • Last Update: 2020-02-17
    • Source: Internet
    • Author: User
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    Wen Jie winter On February 13, Qilu pharmaceutical's application for listing of "pregabalin capsule" according to the four categories of new registration classification has completed the technical review and is in the "approval" status, and will be approved for listing After approval, it shall be deemed to pass the conformity assessment (acceptance No.: cyhs1700315) Pregabalin, trade name lycrica, is a GABA analog developed by Pfizer It has been approved by FDA for the treatment of partial onset diabetic peripheral neuralgia, postherpetic neuralgia, fibromyalgia in adults and partial seizure in patients aged 4 years and over It is 130 worldwide Listed in many countries and regions, it is the best-selling analgesic in the world According to Pfizer's 2019 financial report data, global sales of Lyrica reached US $3.321 billion, down 33% year on year (US $4.97 billion in 2018) In the United States, the Lyrica patent originally expired on December 30, 2018, but the launch of the pediatric epilepsy project gave it an additional six months of market monopoly period Pfizer said that due to the expiration of the patent, since July 2019, several lycrica generic drugs have been approved for listing, resulting in a significant decline in global sales In response to the impact of patent cliff on pregabalin capsule, on October 11, 2017, FDA approved pregabalin sustained-release dosage form, trade name Lyrica Cr, for the management of neuropathic pain related to adult diabetic peripheral neuropathy (PDPN) The ordinary capsule preparation of pregabalin is used twice or three times a day, while Lyrica Cr is taken once a day, which greatly improves the compliance of patients and reduces the side effects brought by multiple oral administration in a day Lyrica CR provides an effective treatment option for patients once a day, and also brings some buffer for Lyrica to cope with the impact of generic drugs From the perspective of domestic market, the sales volume of pregabalin capsule has been growing steadily since it was listed in China Since it was included in the 2017 version of national medical insurance, the market has grown rapidly At present, there are only two kinds of pregabalin ordinary capsule preparations that were originally researched by Pfizer and Chongqing Saiwei Pharmaceutical Co., Ltd approved to be listed in China, and no enterprise has been approved to be a sustained-release tablet dosage form According to the public data, the sales of Pregabalin Capsules in domestic public medical institutions reached 227 million yuan in 2018, of which Pfizer accounted for 70% of the domestic market share, and Chongqing LDK pharmaceutical industry accounted for nearly 30% According to insight database, Chongqing Saiwei Pharmaceutical Co., Ltd has submitted the supplementary application for conformity evaluation of pregabalin capsule After the approval of Qilu pharmaceutical, it will be the first enterprise in China to pass the conformity evaluation Time axis for evaluation of "pregabalin capsule" of Qilu Pharmaceutical (https://db.dxy.cn/v5/jindu? Caseid = cyhs1700315)
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