FDA批准第二个氯化钾口服液
出自识林
FDA批准第二个氯化钾口服液
笔记 2015-09-05 Lachman CONSULTANTS FDA批准第二个氯化钾口服液 — 另一场未获批产品执法行动随之而来? 2015年8月19日,FDA批准了第2个氯化钾口服液505(b)(2)申请,该产品通常是对服用钾消耗利尿药患者的钾替代治疗。之前,FDA已于2014年12月22日批准另外一个药品的505(b)(2)申请。 在此之前,市场上有一些未获批的氯化钾口服液处方药产品,作为“祖父”药品或“DESI(药效研究与实施,drug efficiency study and implementation)相似或相关”药品上市销售。钾替代治疗产品的市场相当大,虽然有无数已获批的固体口服剂型上市销售,但许多患者因种种原因无法服用这些产品。 FDA关于已上市未获批处方药品的合规政策指导概述了FDA的执法重点,并指出,FDA通常不会在批准某个药品的NDA后对未获批版本的相同产品采取行动,除非获得NDA批准的企业能够为整个市场供应该产品。此外,FDA已经表明,可能延迟执法行动,直到医疗专业人员将患者使用的产品替换成为已获批版本产品。 FDA自2006年开始执行的将未获批处方药从市场上撤除的执法行动列表中,并未列出氯化钾口服液产品。不知最近的批准是否将推动FDA对该特定药品的未获批版本展开执法行动? 自2006年起,FDA已努力将未批准处方药从市场上移除,并在减少向公众提供未获批药品数量方面非常成功。最近的执法行动是今年7月份针对未获批滴耳液。在那之前,FDA已经针对一系列未获批就上市的处方产品采取行动。时间证明一切,我们可以认为第二个氯化钾口服溶液的批准可能预示着不久的将来另一执法行动。 Lachman CONSULTANTS - Bob Pollock先生 2015-09-02 Second Potassium Chloride Oral Solution Approved by FDA – Will Enforcement Action follow? On August 19, 2015, the FDA approved a second 505(b)(2) drug application for potassium chloride oral solution, a potassium replacement therapy typically for patients taking potassium-depleting diuretics. Previous to this approval, FDA approved another 505(b)(2) application for the drug on December 22, 2014. Prior to that date, there were a number of marketed unapproved prescription drug products for potassium chloride oral solution on the market as “grandfathered” drugs or “DESI similar and related” drugs. The market for potassium replacement therapy is rather large and, while there are numerous approved solid oral dosage forms available in the marketplace, many patients cannot take those products for various reasons. The FDA's Compliance Policy Guide on Marketed Unapproved Prescription Drug Products (here) outlines FDA's enforcement priorities and notes that FDA will typically not take action against unapproved versions of prescription drug products after approval of an NDA for the same product, unless the firm receiving NDA approval can supply the entire market for the product. In addition, FDA has indicated that enforcement action may be delayed until such time as healthcare professional can switch their patients to the approved version of the product. The listing of enforcement actions FDA has taken since its 2006 push to removed unapproved prescription drugs from the market does not list potassium chloride oral solution products (here). We wonder if this latest approval will spur the Agency to commence enforcement action against the unapproved versions of this specific drug product? FDA has been marching along in its effort to remove unapproved marketed prescription drugs from the market since 2006 and has been very successful in reducing the number of unapproved drugs available to the public. The latest enforcement action was against unapproved ear drops on July of this year (here). Prior to that action, it has been a while since FDA has taken action on a class of unapproved marketed prescription drug products. Only time will tell, but one might think that this second potassium chloride oral solution approval may signal another enforcement action in the near future. |