Source: FDA, National Drug Code (US) Revision Year: 2021
NITYR contains nitisinone, which is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 (HT-1).
Nitisinone occurs as white to yellowish-white, crystalline powder. It is practically insoluble in water, soluble in 2M sodium hydroxide and in methanol, and sparingly soluble in alcohol.
Chemically, nitisinone is 2-(2-nitro-4-trifluoromethylbenzoyl) cyclohexane-1,3-dione, and the structural formula is:
Figure 1:
The molecular formula is C14H10F3NO5 with a relative mass of 329.23.
Each NITYR (nitisinone) tablet contains 2, 5 or 10 mg of nitisinone. Inactive ingredients are: glyceryl dibehenate, and lactose monohydrate. NITYR tablets are intended for oral administration.
| Dosage Forms and Strengths |
|---|
|
Tablets: 2 mg, 5 mg, and 10 mg white to beige, round, flat tablets, which may display light yellow to brown speckles, debossed with “L” on one side and the strength (“2” mg, “5” mg, or “10” mg), on the other side. |
| How Supplied |
|---|
|
Tablets: White to beige, round, flat tablets, which may display light yellow to brown speckles, debossed with the “strength” in mg on one side and “L” on the other side. Each tablet contains 2, 5 or 10 mg nitisinone. NITYR tablets are packed in high-density polyethylene (HDPE) square bottles with a child-resistant tamper-evident polypropylene (PP) screw cap. Each bottle contains 60 tablets. 2 mg tablets: From white to beige, round, flat tablets, which may display light yellow to brown speckles, debossed “2” on one side and “L” on the other side, NDC 70709-002-60 5 mg tablets: From white to beige, round, flat tablets, which may display light yellow to brown speckles, debossed “5” on one side and “L” on the other side, NDC 70709-005-60 10 mg tablets: From white to beige, round, flat tablets, which may display light yellow to brown speckles, debossed “10” on one side and “L” on the other side, NDC 70709-000-60 Manufactured by: PCI Pharma Services, 23-24 Tafarnaubach Industrial Estate, Tredegar, Gwent, NP22 3AA, United Kingdom Rivopharm SA, Centro Insema, 6928 Manno, Switzerland Marketed by: Cycle Pharmaceuticals Ltd., Bailey Grundy Barrett Building, Little St. Mary’s Lane, CB2 1RR, Cambridge, United Kingdom |
| Drug | Countries | |
|---|---|---|
| NITYR | Austria, Estonia, Croatia, Ireland, Israel, Italy, Lithuania, New Zealand, Poland, United States |
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