FDA Approves Generics of ProAir HFA and Daraprim
Albuterol sulfate, pyrimethamine approved for bronchospasm, toxoplasmosis, respectively
MONDAY, March 2, 2020 (HealthDay News) -- Last week, the U.S. Food and Drug Administration approved generic versions of two drugs: one for ProAir HFA (albuterol sulfate) Inhalation Aerosol to treat or prevent bronchospasm and one for Daraprim (pyrimethamine) tablets for treatment of toxoplasmosis when used with a sulfonamide.
The FDA requires that generic prescription drug sponsors submit data and information to show they meet the agency's approval standards. The agency notes that approved generic prescription drugs have the same efficacy and safety as brand-name drugs, and the manufacturing and packaging sites are required to pass the same quality standards.
The generic of ProAir HFA (albuterol sulfate) is indicated in patients aged 4 years and older who have reversible obstructive airway disease. It is also indicated to prevent exercise-induced bronchospasm in patients 4 years and older. The most commonly reported side effects with albuterol sulfate inhalation aerosol are headache, tachycardia, pain, dizziness, pharyngitis, rhinitis, chest pain, palpitations, tremor, and nervousness.
Daraprim (pyrimethamine) for the treatment of toxoplasmosis is contraindicated in patients with a known hypersensitivity to the drug or with megaloblastic anemia due to a folate deficiency. The most commonly reported side effects include hypersensitivity reactions that can be severe, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, erythema, multiforme, anaphylaxis, and hyperphenylalaninemia, in particular when pyrimethamine is administered simultaneously with a sulfonamide. Anorexia and vomiting can occur with doses of pyrimethamine; megaloblastic anemia, leukopenia, thrombocytopenia, pancytopenia, neutropenia, atrophic glossitis, hematuria, and disorders of cardiac rhythm may also occur. The FDA noted a small "starting" dose is recommended in patients with convulsive disorders to avoid potential nervous system toxicity. The drug should be used with caution in patients with impaired renal or hepatic function and in those with possible folate deficiency.
Approval of the generic albuterol sulfate inhalation aerosol was granted to Perrigo Pharmaceutical Co. The approved generic version of Daraprim tablets was sponsored by Cerovene.