Approval is Another Milestone of Viatris’ Ability to Successfully Develop Complex Generic Medicines
Viatris Inc., a global healthcare company listed on Nasdaq as VTRS, announced that the U.S. Food and Drug Administration has approved Iron Sucrose Injection, USP. This intravenous treatment is used to address iron deficiency anemia in adults and children aged two years and older who have chronic kidney disease. Iron deficiency anemia is a common complication in these patients and is associated with increased risks of cardiovascular problems and mortality. Iron Sucrose Injection is the first generic version of Venofer Injection and will soon be available in single-dose vials with strengths of 50 mg per 2.5 mL, 100 mg per 5 mL, and 200 mg per 10 mL.
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Philippe Martin, Chief Research and Development Officer at Viatris, said, “The first FDA approval of a generic iron sucrose is an important step forward for patients with chronic kidney disease and iron deficiency anemia. It shows Viatris has strong technical and manufacturing skills. We developed this complex product ourselves and are happy to have reached this important milestone after working closely with the FDA for years.” Viatris also has a broad pipeline of complex injectable drugs in development, including ferric carboxymaltose injection, another iron replacement therapy.
Corinne Le Goff, Chief Commercial Officer at Viatris, added, “Launching the first generic iron sucrose in the U.S. provides another important treatment choice for patients with chronic kidney disease and iron deficiency. This product will help improve long-term access to necessary therapies. Iron sucrose fits well with Viatris’ global business and supports our generics offerings.” The FDA has granted Viatris a competitive generic therapy designation for the 100 mg/5 mL and 200 mg/10 mL strengths. This designation accelerates approval in markets with limited competition and provides 180 days of market exclusivity following product launch.
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Important safety information includes that Iron Sucrose Injection should not be used by individuals with known allergies to iron sucrose. Serious allergic reactions such as anaphylaxis, which can be life-threatening, have been reported. Symptoms include shock, severe low blood pressure, loss of consciousness, and collapse. If such reactions occur, the infusion must be stopped immediately, and patients monitored closely during and after treatment. Hypotension can also occur and requires careful monitoring, especially related to the infusion rate and dosage. Excessive iron therapy can cause iron overload, leading to hemosiderosis. Patients need regular monitoring of blood and iron parameters, and iron sucrose should not be given to those showing signs of iron overload. Serum iron tests should be avoided for at least 48 hours post-infusion.
Common side effects in adults include diarrhea, nausea, vomiting, headache, dizziness, low blood pressure, itching, limb pain, joint pain, back pain, muscle cramps, injection site reactions, chest pain, and swelling of the limbs. In pediatric patients, frequent side effects include headache, viral respiratory infections, peritonitis, vomiting, fever, dizziness, cough, nausea, blood vessel blockage, and fluctuations in blood pressure. Post-marketing reports have also noted rare but serious immune reactions such as anaphylaxis and angioedema, nervous system effects including seizures and loss of consciousness, cardiovascular issues like slow heart rate and shock, respiratory problems such as bronchospasm, and injection site discoloration due to drug leakage outside the vein. Iron sucrose may also reduce the absorption of oral iron supplements when taken together.
Use during pregnancy requires caution since untreated iron deficiency anemia can negatively affect both mother and baby, but severe reactions like circulatory failure have been reported in pregnant women receiving intravenous iron, especially during the later stages of pregnancy. Elderly patients should be dosed carefully because of an increased likelihood of reduced organ function and multiple health conditions, which may raise the risk of complications.
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