ANDA

1 9.9

A request that asks the U.S. health agency to allow a generic medicine to be sold

noun
/ˈændə/

Formal

: ANDA

Under the ANDA requirements, generic drug makers must show that their drug is the bioequivalent of (the same as) the brand name drug (see details below) -- but they do not have to repeat the drug creators' clinical safety and efficacy trials.

Examples

Once the generic drug company submits its ANDA with that Paragraph IV Certification, it has to notify the brand-name manufacturer, who then may immediately sue for patent infringement.

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As we've previously discussed (here, here, and here), ViroPharma sued the FDA after the agency denied a March 17, 2006 petition for stay of action and approved ANDAs for generic VANCOCIN.

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Filing for the ANDA for MTX is in the 1Q of 2013, but as management says they are way ahead of schedule, I, like others, think it could happen a lot sooner.

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Now generic companies submit much simpler Abbreviated New Drug Applications (ANDAs) to the FDA.

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The pharmaceutical company submitted an ANDA to the FDA to gain approval for their new generic medication.
After reviewing the ANDA, the FDA granted approval for the generic version of the popular drug.
Companies must follow strict guidelines when preparing their ANDA to ensure compliance with FDA regulations.

Surface Forms

ANDA singular

ANDAs plural

Morphology

ANDA = A + N + D + A

This is an acronym formed from initial letters, and the meaning of the regulatory application cannot be inferred from the letters themselves.

Etymology

ANDA stands for Abbreviated New Drug Application, which is a 'short' application sent to the U.S. Food and Drug Administration to ask for approval to sell a generic drug. So, ANDA is the shorter, simpler form of the full application, which is why it refers to the specific approval request for generics.