ORFADIN Capsule / Oral suspension Ref.[10890] Active ingredients: Nitisinone

Source: FDA, National Drug Code (US)  Revision Year: 2019 

Product description

ORFADIN 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:

Capsules: Hard, white-opaque capsule, marked as 2 mg, 5 mg, 10 mg or 20 mg strengths of nitisinone, intended for oral administration. Each capsule contains 2 mg, 5 mg, 10 mg or 20 mg nitisinone, plus pre-gelatinized starch. The capsule shell is gelatin and titanium dioxide and the imprint is an iron oxide.

Oral suspension: 4 mg/mL, a white, slightly viscous opaque suspension. The inactive ingredients are hydroxypropyl methylcellulose, glycerol, polysorbate 80, sodium benzoate, citric acid monohydrate, trisodium citrate dihydrate, strawberry aroma (artificial) and purified water.

Glycerol: Each mL contains 500 mg.

Sodium: Each mL contains 0.7 mg (0.03 mEq).

Dosage Forms and Strengths
  • Capsules: 2 mg, 5 mg, 10 mg and 20 mg white capsules imprinted with “NTBC” followed by “2 mg”, “5 mg”, “10 mg” or “20 mg”, indicating the actual amount of nitisinone in each capsule.
  • Oral suspension: 4 mg/mL, a white, slightly viscous opaque suspension.
How Supplied

Capsules: White capsules marked in black with “NTBC” and identified as 2 mg, 5 mg, 10 mg or 20 mg strengths of nitisinone. The capsules are packed in a high density (HD) polyethylene container with a tamper-resistant low density (LD) polyethylene snap-on cap. Each bottle contains 60 capsules.

  • 2 mg white capsules imprinted “NTBC 2 mg” in black ink, NDC 66658-102-60
  • 5 mg white capsules imprinted “NTBC 5 mg” in black ink, NDC 66658-105-60
  • 10 mg white capsules imprinted “NTBC 10 mg” in black ink, NDC 66658-110-60
  • 20 mg white capsules imprinted “NTBC 20 mg” in black ink, NDC 66658-120-60

Oral suspension: White, slightly viscous opaque suspension. 1 mL contains 4 mg of nitisinone. The suspension is provided in a 100 mL brown bottle (type III glass) with a white child resistant HDPE screw cap with sealing and tamper evidence. Each bottle contains 90 mL oral suspension.

Oral suspension 4 mg/mL, NDC 66658-204-90

Manufactured by: Apotek Produktion & Laboratorier AB, Sweden

Marketed by: Sobi, Inc, 890 Winter Street, Waltham, MA 02451

Drugs

Drug Countries
ORFADIN Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Tunisia, United Kingdom, United States
 
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