New generic Lexapro has same risk profile as brand-name drug
Lupin Pharmaceuticals announced it has received approval from the Food and Drug Administration (FDA) to market Escitalopram Tablets (Escitalopram oxalate), a generic version of the antidepressant Lexapro. The medication is indicated for the treatment of major depressive disorder in adults and adolescents aged 12-17 years. It is also used to treat general anxiety disorder in adults.
Lexapro, and its generic Escitalopram, are in a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs. They are among the most prescribed medications in the United States. Brand-name Lexapro generated approximately $2.7 billion in sales for the year ending June 2012. Other brand-name SSRIs include Paxil, Zoloft, Celexa and Prozac.
Both brand-name and generic versions of SSRIs carry side effects, some of which may be serious.
SSRIs are classified as Category C pregnancy drugs, meaning that animal studies revealed that the drugs may cause defects in developing fetuses, or that no studies have been done in women to determine the birth defect risk. Paxil is the only SSRI that is listed as a Category D drug, meaning there is positive evidence of birth defects in babies born to women who took the medication while pregnant.
However, new studies show that all SSRIs, if taken during pregnancy, may increase the risk of serious birth defects including heart defects, persistent pulmonary hypertension, spina bifida, and malformations.
Escitalopram Tablets USP will be available in 5 mg, 10 mg, and 20 mg dosages and is the AB-rated generic equivalent of Forest’s Lexapro Tablets. AB-rated drugs are ones that meet the necessary bioequivalence standards established by the FDA.
A generic drug is considered bioequivalent to a brand-name drug if it contains the same active ingredient as the branded drug, and if there is no significant difference in the formulation, quality and effectiveness of the two medications. Generic medications generally have the same risk profile as their brand-name equivalents.
Source: Sacramento Bee