East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Ibuprofen Oral Suspension USP, 100 mg/5 mL. Aurobindo’s Ibuprofen Oral Suspension USP are an AB-rated generic equivalent to the reference listed drug Motrin® Oral Suspension.

Ibuprofen Oral Suspension is indicated for the reduction of fever, to relieve pain and to relieve the signs and symptoms of juvenile arthritis in pediatric patients. In adult patients, for the treatment of primary dysmenorrhea and to relieve signs and symptoms of rheumatoid arthritis and osteoarthritis.

The product has an estimated market size of $78.3M for the twelve months ending December 2017 according to IMS*.

Ibuprofen Oral Suspension USP represent the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 291 final approvals, including 38 tentative approvals, and 17 approved products from Aurolife. There are 106 additional products on file with U.S. FDA.

* IMS National Sales Perspectives: Retail and Non-Retail MAT December 2017