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Aurobindo receives FDA approval for deflazacort tablets

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EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application deflazacort tablets, 6mg, 18mg, 30mg, & 36mg. Aurobindo Pharma’s deflazacort tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), EMFLAZA Tablets manufactured by PTC Therapeutics Inc.

Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older.


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