The document highlights patent and regulatory precautions but omits clinical safety warnings.

Regulatory and Legal Precautions

The approval letter emphasizes compliance with patent litigation outcomes (e.g., ‘508, ‘249 patents) and post-approval requirements, including REMS alignment if applicable. However, clinical precautions such as contraindications, drug interactions, or warnings for specific populations (e.g., pregnancy, immunosuppression) are not specified. The ANDA holder must ensure adherence to compendial standards (USP-NF) for quality control. Clinicians should consult the RLD’s safety profile for potential risks until generic-specific data are available.