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After ANDA approval, a generic manufacturer may distribute the drug under the non-proprietary (generic) name and/or develop its own brand name

A) True
B) False

User Spots
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Final answer:

Yes, a generic manufacturer can distribute the drug under a generic name or their own brand name after ANDA approval, which indicates that their product is therapeutically equivalent to the brand name drug.

Step-by-step explanation:

True, after an ANDA approval, a generic manufacturer may indeed distribute the drug under the non-proprietary (generic) name and/or develop its own brand name. The ANDA process allows manufacturers to demonstrate that their product is bioequivalent to the original brand name drug. Once the U.S. Food and Drug Administration (FDA) has determined that the generic drug is interchangeable with the brand name drug, the manufacturer can market it under a generic name or potentially create a new brand name for the product.

The generic drug must still meet the rigorous standards set by the FDA to ensure it is safe and effective for consumers. The ability to market these drugs at a lower cost can make them more accessible to the public, expanding treatment options for various conditions.

User Lorenzo Belli
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