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Aug 7, 2026Regulatory decision8 fact check notes

Actavis Labs UT's clindamycin/benzoyl peroxide gel ANDA shows FDA approval letter dated August 20, 2

A single ANDA record for a topical acne combination gel lists an FDA approval letter dated August 20, 2018, with no other activity noted this week.

  • Clindamycin phosphate and benzoyl peroxide gel, ANDA208757, sponsored by Actavis Labs UT Inc: the record lists an application containing a topical gel with 3.75% benzoyl peroxide and clindamycin phosphate equivalent to 1.2% base, filed as an original ANDA submission with standard review priority.1 The application file includes an approval letter document dated August 20, 2018.

Fact check notes

  • ImpreciseANDA208757 record lists an FDA approval letter dated August 20, 2018Source labels the document simply as type 'Letter', not explicitly 'approval letter'; the approval inference comes from submission_status AP, which is a reasonable but unstated leap.
  • ImpreciseDescribed as a 'topical acne combination gel'Source does not mention the indication 'acne'; this is a reasonable inference from the known use of the drug combination but is not stated in the record.
  • ImpreciseActavis Labs UT's clindamycin/benzoyl peroxide gel ANDA shows FDA approval letter dated August 20, 2The headline correctly identifies ANDA208757, Actavis Labs UT, and the letter date but truncates the date to 'August 20, 2' instead of 'August 20, 2018', and the document is only labeled 'Letter' in the source, not explicitly an 'approval letter' (though submission_status is AP, the type field itself is generic).
  • Checker's noteHeadline truncates the approval letter date to 'August 20, 2' instead of the full 'August 20, 2018'.
  • Checker's noteThe document is only labeled 'Letter' in the source metadata; calling it an 'approval letter' is an inference not explicitly stated, though consistent with the AP submission status.
  • Checker's noteThe summary frames the finding as 'this week's filing activity,' a timeframe not supported by the source data.
  • Checker's noteThe 'acne' indication is not explicitly stated in the source record.
  • Sentence removedThis week's filing activity for the company was limited to one ANDA record for a topical combination product.unsupported: Source contains only a single record with no mention of a weekly timeframe or company-wide activity scope; the 'this week' framing is not supported by the data provided.

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Where the check questioned a sentence, its note is shown above. Not investment advice.