Aurobindo Pharma Limited today announced that it has received final approval form the US Food and Drug Administration(USFDA) to manufacture and market Dexamethasone Sodium Phosphate Injection. The product is expected to be launched by the fourth quarter of the current financial year, the company said.
The drug product is a bio-equivalent equivalent and therapeutically equivalent to the reference listed drug product of Luitpold Pharmaceuticals Inc. The approved product has an estimated market size of $ 31 million for the twelve month period ending September 2015, according to a company press release.
Dexamethasone Sodium Phosphate injection is used in the treatment of various conditions including allergic reactions, arthritiis among other diseases.
Aurobindo now has 17 abbreviated new drug applications(ANDAs) approved out of Unit IV formulation facility in Hyderabad for manufacturing general injectable products. The company now has a total of 220 ANDA approvals, including 192 final approvals, from the USFDA, it said.
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