Generic erectile dysfunction drugs must meet rigorous standards before receiving FDA approval. This involves extensive testing to demonstrate bioequivalence to the brand-name drug.
Manufacturers submit a comprehensive application, including data from preclinical studies and clinical trials. These trials show the generic drug works the same way as the original, matching its absorption rate, bioavailability, and therapeutic effect.
The FDA reviews the application, scrutinizing manufacturing processes and quality control measures. They verify the generic drug’s purity, potency, and stability.
Once approved, the generic drug undergoes ongoing surveillance. The FDA monitors post-market safety data, allowing for prompt action if any problems arise.
This process ensures patients receive safe and effective medications at a lower cost. The rigorous testing guarantees bioequivalence to brand-name drugs, providing reliable treatment options.
