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Reddy's on April 28, 2026 [9] and Apotex on May 1, 2026 [10]) after the data exclusivity period expired on January 4, 2026
During this period, FDA has stated it will not take enforcement action against compounders who continue to make tirzepatide products.) While it is highly likely that FDA will not address either Novo Nordisks or Eli Lilly and Companys submission until after the Proposed Rule is finalized, it is important that any entities compounding these drugs are aware that further changes to the rules may impact their ability to compound such drugs in the near future
This has important implications for procedural planning and perioperative care, which should follow local clinical guidelines and individual risk assessment
Adverse reactions reported in greater than or equal to 2% of phentermine and topiramate extended-release-treated adults and more frequently than in the placebo group are shown in Table 1
