Final answer:
Approval of an SNDA for OTC status for one generic drug manufacturer does not automatically allow other generics the same status; each must submit its own application to the FDA. Generic drugs must show therapeutic equivalence to brand-name drugs and meet FDA safety and efficacy standards.
Step-by-step explanation:
When a generic drug manufacturer wants their product to become an Over-the-Counter (OTC) medication, they may submit a Supplemental New Drug Application (SNDA) to the U.S. Food and Drug Administration (FDA). However, approval of an SNDA for OTC status for one generic manufacturer does not automatically confer OTC status to all other generics of the same branded drug. Each generic manufacturer would typically have to submit their own SNDA to obtain permission for OTC sale, as regulatory approvals are not necessarily universal across all brands or versions of a drug.
To elaborate, generic drugs must demonstrate therapeutic equivalence to the brand-name drug and may become available after the original drug's patent expires. The safety and efficacy standards enforced by the FDA ensure that generic drugs are held to high-quality standards and are interchangeable with their branded counterparts when prescribed by healthcare providers. The move from prescription status to OTC status represents a significant change in how the drug can be accessed by consumers and requires a separate, rigorous evaluation process by the FDA to ensure the drug is safe for use without a medical practitioner’s supervision.