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Aurobindo’s generic Seroquel XR receives FDA approval




Aurobindo Pharma has received US Food and Drug Administration approval for its quetiapine fumarate extended-release tablets (50mg, 150mg, 200mg, 300mg, and 400mg). The medication is a bioequivalent of the AstraZeneca drug Seroquel XR and is therapeutically equivalent to this product. 

Quetiapine fumarate is used to treat a number of conditions, including schizophrenia and manic or mixed episodes associated with bipolar disorder. It may also be prescribed as an adjunct therapy to antidepressants as a treatment for major depressive disorder. Adjunct therapies are treatments used alongside the primary treatment. 

The drug is contraindicated in patients with an allergy to quetiapine and it is not approved for use treating psychotic conditions related to dementia. Quetiapine is only indicated for use in adults and should not be used to treat patients under 18 years of age. It also should not be taken alongside certain other medications, including some antibiotics, antidepressants, heart rhythm medication, and antipsychotics, among others.

Common side effects of quetiapine fumarate extended-release may include dizziness, weakness, increased appetite, trouble with movement, sore throat, dry mouth, nausea, vomiting, stomach pain, and constipation. Patients with concerns about any side effects or possible drug interactions should contact their doctor for medical advice. 

Generic medication accounts for nearly nine out of ten prescriptions filled in the United States, according to the seventh annual Generic Drug Savings in the United States Report compiled by the IMS Institute for Healthcare Informatics on behalf of the Generic Pharmaceutical Association. The study estimated that between 2005 and 2014, generic drug use saved the healthcare system $1.68 trillion. 

To gain FDA approval, generic medicine needs to have the same active ingredient, strength, use indications, form, and route of administration as the innovator drug. Drug companies must demonstrate that the generic medicine can be effectively substituted for its brand-name counterpart, yet still provide the same clinical benefits.