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SITAGLIPTIN-TEVA, TE-SITAGLIPTIN, SITAGLIPTIN-TV (Teva Pharma Australia Pty Ltd)

Product name
SITAGLIPTIN-TEVA, TE-SITAGLIPTIN, SITAGLIPTIN-TV
Sponsor
Teva Pharma Australia Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
116 (255 working days)
Active ingredients
sitagliptin malate
Registration type
New generic medicine
Indication

SITAGLIPTIN-TEVA, TE-SITAGLIPTIN, SITAGLIPTIN-TV (film coated tablet) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:

  • monotherapy when metformin is considered inappropriate due to intolerance; or
  • in combination with other anti-hyperglycaemic agents, including insulin

    • [see 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials, 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS for available data on different add-on combination therapies].

    Registration process

    First generic
    First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine