Source: FDA, National Drug Code (US) Revision Year: 2023
Leniolisib is a kinase inhibitor. The chemical name for leniolisib phosphate is 1-[(3S)3[[5,6,7,8-Tetrahydro-6-[6-methoxy-5-(trifluoromethyl)-3-pyridinyl]pyrido[4,3-d]pyrimidin-4-yl]amino]-1-pyrrolidinyl]-1-propanone phosphate (1:1).
Leniolisib phosphate has the following structural formula:
The molecular formula is C21H25F3N6O2•H3PO4 and the molecular weight is 450.47 g/mol for the free base, 548.46 g/mol for the phosphate salt.
Leniolisib phosphate is a white to yellowish to yellowish-greenish powder. The aqueous solubility of leniolisib phosphate is pH dependent with decreasing solubility observed with increasing pH.
JOENJA film-coated tablets are for oral administration. Each tablet contains 70 mg of leniolisib (equivalent to 85 mg leniolisib phosphate) with the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablet film-coating contains hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, polyethylene glycol, talc, and titanium dioxide.
| Dosage Forms and Strengths |
|---|
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Tablets: 70 mg (leniolisib), yellow, oval-shaped, biconvex, bevelled edge film-coated tablet debossed with “70” on one side and “LNB” on the other side. |
| How Supplied |
|---|
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JOENJA is available in 70 mg tablet: yellow, oval-shaped, biconvex, bevelled edge film-coated tablet debossed with “70” on one side and “LNB” on the other side. It is supplied in bottles with a child-resistant cap of 60 tablets (NDC 71274-170-60). Manufactured for: Pharming Healthcare Inc., 10 Independence Blvd., Warren, NJ USA 07059 |
| Drug | Countries | |
|---|---|---|
| JOENJA | United States |
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