Aurobindo Pharma Ltd has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Naproxen Sodium Tablets USP, 220 mg (OTC). This product is expected to be launched in Q1 of financial year 2016-17.

• The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Aleve Tablets of Bayer Healthcare LLC (Bayer).
• Naproxen Sodium Tablets is used in the treatment and prevention of osteoporosis in postmenopausal women. The approved product has an estimated market size of $96 million for the 12 months ending January 2016.
• This is the 66th ANDA (including 14 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad for manufacturing oral non-antibiotic products.
• Aurobindo now has 245 ANDA approvals (210 final approvals, including 10 from Aurolife Pharma LLC and 35 tentative approvals) from USFDA.

Did You Know?

• Women get osteoporosis more often than men.
• The older you are, the greater your risk of osteoporosis.
• Osteoporosis tends to run in families. If a family member has osteoporosis or breaks a bone, there is a greater chance that you will too.
• Too much alcohol can cause bone loss and broken bones.
• A healthy diet with enough calcium and vitamin D helps make your bones strong.
• Exercise helps your bones grow stronger.