FDA Approval for Generic Drugs

Generic Drugs pic

Generic Drugs
Image: fda.gov

An authorized distributor of generic drugs, DV Medical Supply, Inc., works closely with pharmaceutical companies and individuals in the medical profession. Family-owned and managed since 1977, DV Medical Supply delivers high quality generics with competitive product and shipping prices.

Defined as pharmaceutical compounds manufactured by third parties once the brand name patent expires, generic drugs are equivalent to the brand name compound in terms of dosage, potency, and safety. To apply for FDA approval for a generic drug, manufacturers must submit a document known as the Abbreviated New Drug Application (ANDA). Once the application is approved, manufacturers can begin producing the drug and selling it according to the guidelines put forth by the FDA.

New drugs must submit a New Drug Application (NDA) and complete several phases of animal and human studies before receiving FDA approval. Because generic drugs are bioequivalent to brand-name compounds, which have already completed clinical trials, they do not require the same level of rigor. The ANDA must only demonstrate that the generic compound is bioequivalent to the original, accomplished by measuring absorption of the compound in 24 to 36 healthy volunteers. This standard was codified in the 1984 Waxman-Hatch Act.


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