USFDA approves Aurobindo's drugs for diarrhoea, allergy

Aurobindo now has a total of 224 'Abbreviated New Drug Application' approvals from USFDA

Aurobindo Pharma on Thursday said it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market two drugs used for treating diarrhoea and allergy.

The first, Loperamide Hydrochloride tablet, is used to control symptoms of diarrhoea, including travelers' diarrhoea. The approved product has an estimated market size of $9.7 million for the 12 months ending October 2015, according to IMS Health.

The other, Methylprednisolone Sodium Succinate injection, is a lyophilised product used in the treatment of various medical conditions such as allergic states and disorders. The approved product - USP 40 mg/vial, 125 mg/vial, 500 mg/vial, and 2 g/vial - has an estimated market size of $102 million for the 12 months ending October 2015, as per IMS Health.

Aurobindo now has a total of 224 Abbreviated New Drug Application (ANDA) approvals (196 final approvals, including 10 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.