Aurobindo gets US FDA nod to market injectable form of Warner Chilcot’s Actonel tablets

Aurobindo Pharma on Wednesday said it has received final approval of the US health regulator to manufacture and market its dexamethasone sodium phosphate injection, used to treat various conditions such as severe allergic reactions, arthritis and blood diseases.

Aurobindo Pharma said it has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Risedronate Sodium tablets USP, 5 mg, 30 mg and 35 mg (ANDA 200296). This approval is an extension of tentative approval received on 10 October 2012. This product is ready for launch.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Actonel tablets of Warner Chilcott Co, LLC.

Risedronate Sodium tablets are used in the treatment of osteoporosis. The approved product has an estimated market size of $113 million for the twelve months ending October 2015 according to IMS.

Aurobindo now has a total of 219 ANDA approvals (191 final approvals, including 10 from Aurolife Pharma LLC and 28 Tentative approvals) from USFDA.

The company expects to launch the product by fourth quarter of the current fiscal year, it added.

"The approved product has an estimated market size of $31 million for the twelve months ending September 2015, according to IMS," Aurobindo Pharma said.

The company's injection is generic, equivalent to Luitpold Pharmaceuticals Inc's dexamethasone sodium phosphate injection in the strength of 4 mg/mL, it added.

Dexamethasone Sodium Phosphate injection is used in the treatment of various conditions such as severe allergic reactions, arthritis, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders and skin diseases, the drug maker said.

The Hyderabad-headquartered company has a total of 220 Abbreviated New Drug Application (ANDA) approvals (192 final approvals, including 10 from Aurolife Pharma LLC and 28 tentative approvals) from the US regulator.

Headquartered at Hyderabad, Aurobindo Pharmaceuticvals manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company's manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, Japan PMDA, WHO, Health Canada, MCC South Africa, ANVISA Brazil.

The company's robust product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergies, supported by an outstanding R&D set-up. The Company is marketing these products globally, in over 150 countries.