PMDA · MHLW · monthly list
All drugs approved in Japan in June 2024, in English.
Last updated: 2026-10-02 · 25 approvals
Japan approved 25 drugs in June 2024 (approval date: 2024-06-24): 11 new active ingredient, 9 new indication, 2 new dosage, 1 new dosage form, 1 new combination, 1 biosimilar. Median lag vs FDA for this month: 1.7 years (638 days) (n=8).
| Approved | Brand | Generic (INN) | Company | Indication | Approval type | FDA date | EMA date | Lag vs FDA | Lag vs EMA | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-06-24 | Zavicefta ザビセフタ | Avibactam sodium/Ceftazidime hydrate アビバクタムナトリウム/セフタジジム水和物 | Pfizer Japan Inc. ファイザー(株) | Treatment of sepsis, pneumonia, cystitis, pyelonephritis, peritonitis, intra-abdominal abscess, cholecystitis, and liver abscess caused by Zavicefta-sensitive Escherichia coli, Citrobacter spp., Klebsiella spp., Enterobacter spp., Serratia spp., Proteus spp., Morganella morganii, Haemophilus influenzae, and Pseudomonas aeruginosa 本剤に感性の大腸菌、シトロバクター属、クレブシエラ属、エンテロバクター属、セラチア属、プロテウス属、モルガネラ・モルガニー、インフルエンザ菌、緑膿菌による敗血症、肺炎、膀胱炎、腎盂腎炎、腹膜炎、腹腔内膿瘍、胆嚢炎、肝膿瘍 | New active ingredient standard | 2015-02-25 | 2016-06-23 | 3,407 d 9.3 y | 2,923 d 8.0 y | [1] [2] [3] [4] [5] |
| 2024-06-24 | Vtama ブイタマー | Tapinarof タピナロフ | Japan Tobacco Inc. 日本たばこ産業(株) | Treatment of atopic dermatitis and plaque psoriasis アトピー性皮膚炎、尋常性乾癬 | New active ingredient standard | 2022-05-23 | — | 763 d 2.1 y | — | [1] [2] [3] [4] |
| 2024-06-24 | Typhim Vi タイフィム ブイアイ | Salmonella typhi (TY2 strain) purified Vi capsular polysaccharide 精製チフス菌Vi多糖体 | Sanofi K.K. サノフィ(株) | Prevention of typhoid fever 腸チフスの予防 | New active ingredient standard | — | — | — | — | [1] [2] [3] |
| 2024-06-24 | Trulicity トルリシティ | Dulaglutide デュラグルチド(遺伝子組換え) | Eli Lilly Japan K.K. 日本イーライリリー(株) | （1） A drug with a new dosage for the treatment of type 2 diabetes mellitus. （2） A drug with a new dosage in an additional dosage form for the treatment of type 2 diabetes mellitus 2型糖尿病 | New dosage form standard | — | — | — | — | [1] [2] [3] |
| 2024-06-24 | Targretin タルグレチン | Bexarotene ベキサロテン | Minophagen Pharmaceutical Co., Ltd. (株)ミノファーゲン製薬 | Treatment of adult T-cell leukemia/lymphoma with skin lesions 皮膚病変を有する成人T細胞白血病リンパ腫 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-06-24 | Skyrizi スキリージ | Risankizumab リサンキズマブ(遺伝子組換え) | AbbVie GK アッヴィ(同) | 1) A drug with a new indication and a new dosage for the remission induction therapy of moderate to severe ulcerative colitis (for use only in patients who have not sufficiently responded to conventional treatments). (2) (3) Drugs with a new indication and a new dosage in an additional dosage form for the maintenance therapy for moderate to severe ulcerative colitis (for use only in patients who have not sufficiently responded to conventional treatments) (1) 中等症から重症の潰瘍性大腸炎の寛解導入療法(既存治療で効果不十分な場合に限る) (2) (3) 中等症から重症の潰瘍性大腸炎の維持療法(既存治療で効果不十分な場合に限る) | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-06-24 | Retevmo レットヴィモ | Selpercatinib セルペルカチニブ Orphan | Eli Lilly Japan K.K. 日本イーライリリー(株) | Treatment of RET fusion gene-positive advanced or recurrent solid tumor RET融合遺伝子陽性の進行・再発の固形腫瘍 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2024-06-24 | Relvar 小児用レルベア | Fluticasone furoate/Vilanterol trifenatate フルチカゾンフランカルボン酸エステル/ビランテロールトリフェニル酢酸塩 | GlaxoSmithKline K.K. グラクソ・スミスクライン(株) | Treatment of bronchial asthma (when a combination treatment of an inhaled steroid and a long-acting beta-2 agonist is needed). (3) (4) Drugs with a new additional pediatric dosage indicated for the treatment of bronchial asthma (when a combination treatment of an inhaled steroid and a long-acting beta-2 agonist is needed) 気管支喘息(吸入ステロイド剤及び長時間作動型吸入β2刺激剤の併用が必要な場合) | New combination standard | — | — | — | — | [1] [2] [3] |
| 2024-06-24 | Paraplatin パラプラチン | Carboplatin カルボプラチン | Clinigen K.K. クリニジェン(株) | Treatment of endometrial cancer 子宮体癌 | New indication standardpublic-knowledge | — | — | — | — | [1] [2] [3] |
| 2024-06-24 | Omjjara オムジャラ | Momelotinib hydrochloride hydrate モメロチニブ塩酸塩水和物 | GlaxoSmithKline K.K. グラクソ・スミスクライン(株) | Treatment of myelofibrosis 骨髄線維症 | New active ingredient standard | 2023-09-15 | 2024-01-25 | 283 d 0.8 y | 151 d 0.4 y | [1] [2] [3] [4] [5] |
| 2024-06-24 | Nexium ネキシウム | Esomeprazole magnesium hydrate エソメプラゾールマグネシウム水和物 | AstraZeneca K.K. アストラゼネカ(株) | Prevention of recurrent reflux esophagitis and gastric or duodenal ulcer after dosing non-steroid anti-inflammatory drugs, and prevention of recurrent gastric or duodenal ulcer after dosing low-dose aspirins 逆流性食道炎、非ステロイド性抗炎症薬投与時における胃潰瘍又は十二指腸潰瘍の再発抑制、低用量アスピリン投与時における胃潰瘍又は十二指腸潰瘍の再発抑制 | New dosage standard | — | — | — | — | [1] [2] [3] |
| 2024-06-24 | Livtencity リブテンシティ | Maribavir マリバビル | Takeda Pharmaceutical Company Limited 武田薬品工業(株) | Treatment of cytomegalovirus disease in organ transplantation (including hematopoietic stem cell transplantation) that is refractory to conventional anti-cytomegalovirus therapy 臓器移植(造血幹細胞移植も含む)における既存の抗サイトメガロウイルス療法に難治性のサイトメガロウイルス感染症 | New active ingredient orphanpriority | 2021-11-23 | 2022-11-09 | 944 d 2.6 y | 593 d 1.6 y | [1] [2] [3] [4] [5] |
| 2024-06-24 | Jaypirca ジャイパーカ | Pirtobrutinib ピルトブルチニブ | Eli Lilly Japan K.K. 日本イーライリリー(株) | Treatment of relapsed or refractory mantle cell lymphoma with resistance or intolerance to other BTK inhibitors 他のBTK阻害剤に抵抗性又は不耐容の再発又は難治性のマントル細胞リンパ腫 | New active ingredient standard | 2023-01-27 | 2023-10-30 | 514 d 1.4 y | 238 d 0.7 y | [1] [2] [3] [4] [5] |
| 2024-06-24 | Haiyitan ハイイータン | Gumarontinib hydrate グマロンチニブ水和物 | Haihe Biopharma K. K. 海和製薬(株) | Treatment of unresectable advanced or recurrent MET exon 14 (METex14) skipping mutation-positive non-small cell lung cancer MET遺伝子エクソン14スキッピング変異陽性の切除不能な進行・再発の非小細胞肺癌 | New active ingredient standard | — | — | — | — | [1] [2] [3] |
| 2024-06-24 | Fabhalta ファビハルタ | Iptacopan hydrochloride hydrate イプタコパン塩酸塩水和物 | Novartis Pharma K.K. ノバルティス ファーマ(株) | Treatment of paroxysmal nocturnal haemoglobinuria 発作性夜間ヘモグロビン尿症 | New active ingredient standard | 2023-12-05 | 2024-05-17 | 202 d 0.6 y | 38 d 0.1 y | [1] [2] [3] [4] [5] |
| 2024-06-24 | Ezharmia エザルミア | Valemetostat tosilate バレメトスタットトシル酸塩 | Daiichi Sankyo Company, Limited 第一三共(株) | Treatment of relapsed or refractory peripheral T-cell lymphoma 再発又は難治性の末梢性T細胞リンパ腫 | New indication standardsakigake | — | — | — | — | [1] [2] [3] |
| 2024-06-24 | Covgoze コブゴーズ | Recombinant coronavirus (SARS-CoV-2) spike protein antigen 組換えコロナウイルス(SARS-CoV-2)スパイクたん白質抗原 | Shionogi & Co., Ltd. 塩野義製薬(株) | Prevention of disease caused by SARS-CoV-2 infection (COVID-19) SARS-CoV-2による感染症の予防 | New active ingredient priority | — | — | — | — | [1] [2] [3] |
| 2024-06-24 | Cellcept セルセプト | Mycophenolate mofetil ミコフェノール酸 モフェチル | Chugai Pharmaceutical Co., Ltd. 中外製薬(株) | Treatment of systemic sclerosis-associated interstitial lung disease 全身性強皮症に伴う間質性肺疾患 | New indication standardpublic-knowledge | — | — | — | — | [1] [2] [3] |
| 2024-06-24 | Briviact ブリィビアクト | Brivaracetam ブリーバラセタム | UCB Japan Co., Ltd. ユーシービージャパン(株) | Treatment of partial seizures (including secondary generalized seizures) in patients with epilepsy. (3) A drug with a new active ingredient indicated for the following treatment; partial seizures (including secondary generalized seizures) in patients with epilepsy. It is used as an alternative therapy for blevaracetam oral formulation in patients who are temporarily unable to be administered orally (1) (2) てんかん患者の部分発作(二次性全般化発作を含む) (3) 一時的に経口投与ができない患者における、下記の治療に対するブリーバラセタム経口製剤の代替療法 てんかん患者の部分発作(二次性全般化発作を含む) | New active ingredient standard | 2016-02-18 | 2016-01-13 | 3,049 d 8.3 y | 3,085 d 8.4 y | [1] [2] [3] [4] [5] |
| 2024-06-24 | Botox ボトックス | Botulinum toxin type A A型ボツリヌス毒素 | GlaxoSmithKline K.K. グラクソ・スミスクライン(株) | Treatment of upper and lower limb spasticity 上肢及び下肢痙縮 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-06-24 | Benlysta ベンリスタ | Belimumab ベリムマブ(遺伝子組換え) | GlaxoSmithKline K.K. グラクソ・スミスクライン(株) | Treatment of systemic lupus erythematosus in patients who have not responded sufficiently to conventional treatments 既存治療で効果不十分な全身性エリテマトーデス | New dosage standard | — | — | — | — | [1] [2] [3] |
| 2024-06-24 | Awiqli アウィクリ | Insulin icodec インスリン イコデク(遺伝子組換え) | Novo Nordisk Pharma Ltd. ノボ ノルディスク ファーマ(株) | Treatment of diabetes mellitus in cases where insulin therapy is indicated インスリン療法が適応となる糖尿病 | New active ingredient standard | 2026-03-26 | 2024-05-17 | 640 d earlier Japan first | 38 d 0.1 y | [1] [2] [3] [4] [5] |
| 2024-06-24 | Avigan アビガン | Favipiravir ファビピラビル Orphan | Fujifilm Toyama Chemical Co., Ltd. 富士フイルム富山化学(株) | Treatment of severe fever with thrombocytopenia syndrome virus infection 重症熱性血小板減少症候群ウイルス感染症 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2024-06-24 | Alhemo アレモ | Concizumab コンシズマブ(遺伝子組換え) | Novo Nordisk Pharma Ltd. ノボ ノルディスク ファーマ(株) | Control of bleeding tendency in patients with congenital haemophilia who do not have inhibitors against blood coagulation factor VIII or IX 血液凝固第VIII因子又は第IX因子に対するインヒビターを保有しない先天性血友病患者における出血傾向の抑制 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-06-24 | Aflibercept BS アフリベルセプトBS硝子体内 | Aflibercept [aflibercept biosimilar 1] アフリベルセプト(遺伝子組換え)[アフリベルセプト後続1] | Global Regulatory Partners GK グローバルレギュラトリーパートナーズ(合) | A biosimilar indicated for the treatment of macular edema following retinal vein occlusion, choroidal neovascularization in patients with pathologic myopia, and diabetic macular edema 網膜静脈閉塞症に伴う黄斑浮腫、病的近視における脈絡膜新生血管及び糖尿病黄斑浮腫 | Biosimilar standard | — | — | — | — | [1] [2] [3] |
Click a column header to sort. Lag = days between the FDA (or EMA) approval and the Japanese approval of the same active ingredient; “Japan first” means Japan approved it earlier. Lag is shown only when a matching foreign approval was found. JP = no English name found; Japanese kept.
Source: PMDA / MHLW (PDL1.0). Unofficial English translation, edited by Japan Pharma Regulatory Brief.
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