Aurobindo gets FDA nod for methotrexate tablets

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EAST WINDSOR, N.J. – Aurobindo has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application methotrexate tablets USP, 2.5 mg. Aurobindo’s methotrexate tablets USP, 2.5 mg are an AB-rated generic equivalent to the reference listed drug (RLD), Rheumatrex Tablets, 2.5 mg, of DAVA Pharmaceuticals.

Methotrexate tablets are indicated for:

  1. The treatment of gestational choriocarcinoma, chorio-adenoma destruens and hydatidiform mole.
  2. The symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation.
  3. The management of selected adults with severe, active, rheumatoid arthritis (ACR criteria), or children with active polyarticular-course juvenile rheumatoid arthritis, who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).



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