PMDA · MHLW · monthly list
All drugs approved in Japan in August 2024, in English.
Last updated: 2026-10-02 · 8 approvals
Japan approved 8 drugs in August 2024 (approval date: 2024-08-28): 6 new indication, 2 new dosage.
| Approved | Brand | Generic (INN) | Company | Indication | Approval type | FDA date | EMA date | Lag vs FDA | Lag vs EMA | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-08-28 | Truvada ツルバダ | Emtricitabine/ Tenofovir disoproxil fumarate エムトリシタビン/テノホビル ジソプロキシルフマル酸塩 | Gilead Sciences, Inc. ギリアド・サイエンシズ(株) | Pre-exposure prophylaxis against HIV-1 infection HIV-1感染症の曝露前予防 | New indication standardpublic-knowledge | — | — | — | — | [1] [2] [3] |
| 2024-08-28 | Prevenar20 プレベナー | Pneumococcal polysaccharide conjugated to CRM197 carrier protein 肺炎球菌莢膜ポリサッカライド-CRM197結合体 | Pfizer Japan Inc. ファイザー(株) | Prophylaxis of pneumococcal disease in the elderly and in individuals who are considered to be at a high risk of pneumococcal disease 高齢者及び肺炎球菌による疾患に罹患するリスクが高いと考えられる者における肺炎球菌による感染症の予防 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-08-28 | Pemetrexed ペメトレキセド | Pemetrexed sodium hemipentahydrate ペメトレキセドナトリウムヘミペンタ水和物 | Nippon Kayaku Co., Ltd. 日本化薬(株) | Preoperative adjuvant treatment for non-squamous non-small cell lung cancer 扁平上皮癌を除く非小細胞肺癌における術前補助療法 | New dosage standard | — | — | — | — | [1] [2] [3] |
| 2024-08-28 | Nucala ヌーカラ | Mepolizumab メポリズマブ(遺伝子組換え) | GlaxoSmithKline K.K. グラクソ・スミスクライン(株) | Treatment of chronic rhinosinusitis with nasal polyps (for use only in patients who have not responded sufficiently to conventional treatments) 鼻茸を伴う慢性副鼻腔炎(既存治療で効果不十分な患者に限る) | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-08-28 | Keytruda キイトルーダ | Pembrolizumab ペムブロリズマブ(遺伝子組換え) | MSD K.K. MSD(株) | Preoperative and postoperative adjuvant treatment for non-small cell lung cancer 非小細胞肺癌における術前・術後補助療法 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-08-28 | Azilva アジルバ | Azilsartan アジルサルタン | Takeda Pharmaceutical Company Limited 武田薬品工業(株) | Treatment of hypertension 高血圧症 | New dosage standard | — | — | — | — | [1] [2] [3] |
| 2024-08-28 | Alimta アリムタ | Pemetrexed sodium hydrate ペメトレキセドナトリウム水和物 | Eli Lilly Japan K.K. 日本イーライリリー(株) | Preoperative adjuvant treatment for non-squamous non-small cell lung cancer 扁平上皮癌を除く非小細胞肺癌における術前補助療法 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-08-28 | Alecensa アレセンサ | Alectinib hydrochloride アレクチニブ塩酸塩 Orphan | Chugai Pharmaceutical Co., Ltd. 中外製薬(株) | Postoperative adjuvant treatment for anaplastic lymphoma kinase (ALK) fusion gene-positive non-small cell lung cancer ALK融合遺伝子陽性の非小細胞肺癌における術後補助療法 | New indication orphanpriority | — | — | — | — | [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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