Wednesday, October 7, 2015

Jubilant Life gets USFDA nod to market Indomethacin capsule

Jubilant Life Sciences has received approval from the US health regulator to market Indomethacin capsule used for treating pains.

In a BSE filing, Jubilant Life Sciences said it: “received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (USFDA) for Indomethacin ER Capsule 75mg, which is a non-steroidal anti-inflammatory drug used for treatment of pain’’.

Jubilant Life Sciences said as on June 30, 2015, it had a total of 815 filings for formulations of which 389 have been approved in various regions globally.

“This includes 72 ANDAs filed in the US, of which 38 have been approved, and 46 Dossier filings in Europe,” it added.

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