USFDA approves India-made Dexamethasone injection

Dexamethasone Sodium Phosphate injection had an estimated market size of $31 million for the twelve months till September 2015 The Dollar Business Bureau

USFDA approves India-made Dexamethasone Sodium Phosphate injection

So far, Aurobindo Pharma Ltd. has acquired 17 ANDAs (including one tentative approval) approvals for manufacturing general injectable products

Indian drug major Aurobindo Pharma Ltd. on Wednesday announced that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dexamethasone Sodium Phosphate Injection USP, 4 mg/mL (1 mL, 5 mL and 30 mL vials). "The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Dexamethasone Sodium Phosphate injection USP, 4 mg/mL, of Luitpold Pharmaceuticals Inc.," Aurobindo Pharma Ltd. said in a statement. Dexamethasone Sodium Phosphate injection is used for the treatment of severe allergic reactions, arthritis, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders and skin diseases. The product is expected to be launched by the end of 2015-16. The product has an estimated market size of $31 million for the twelve months till September 2015. So far, Hyderabad-headquartered Aurobindo Pharma Ltd. has acquired 17 ANDAs (including one tentative) approvals for manufacturing general injectable products. The company has a total of 220 ANDA approvals (192 final approvals, including 10 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA. The company's manufacturing facilities have received approvals from several leading regulatory agencies like USFDA, UK MHRA, Japan PMDA, WHO, Health Canada, MCC South Africa and ANVISA Brazil.

December 02, 2015 | 05:25pm IST

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The Dollar Business Bureau - Dec 02, 2015 12:05 IST

USFDA approves India-made Dexamethasone injection

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