Aurobindo gets FDA nod for two drugs

Aurobindo gets FDA nod for two drugs
Highlights

City-based Aurobindo Pharma Limited has received approval from Food & Drug Administration (USFDA) to manufacture and market two drugs, Methylprednisolone Sodium Succinate injection and Loperamide Hydrochloride tablet.

Hyderabad: City-based Aurobindo Pharma Limited has received approval from Food & Drug Administration (USFDA) to manufacture and market two drugs, Methylprednisolone Sodium Succinate injection and Loperamide Hydrochloride tablet.

First drug, Methylprednisolone Sodium Succinate Injection, is a lyophilized product used in the treatment of various medical conditions such as allergic states, disorders, etc. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Solu-Medrol of Pharmacia & Upjohn Co.

The drug has an estimated market size of $102 million for the twelve months ending October 2015, according to IMS. Another drug, Loperamide Hydrochloride 2mg, which also received USFDA nod, is used to control symptoms of diarrhea, including Travelers’ diarrhea.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Imodium A-D Tablets, 2 mg, of Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division. This product is expected to be launched in Q4 this fiscal.

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