Pronunciation: [sˈuːpakmə] (IPA) 
The word "SUPACMR" may seem like a jumbled mess of letters, but its spelling can be broken down using the International Phonetic Alphabet (IPA). The letters "S," "U," and "P" are pronounced as their normal sounds, followed by the long "A" sound in "hay" and a hard "K" sound. The final three letters, "C," "M," and "R," are pronounced as "see," "em," and "are" respectively. Together, the word is pronounced "soo-pa-kam-er" using IPA.
"SupACMR" is an acronym that stands for "Supplemental Abbreviated New Drug Application (ANDA) for Certain Modified Release Drug Products." It is a regulatory term used by the United States Food and Drug Administration (FDA) to refer to a specific type of application submitted by pharmaceutical companies for the approval of generic modified-release drug products.
Modified-release drugs are designed to release their active ingredients gradually over an extended period, allowing for improved drug delivery and potentially reducing dosing frequency. The SupACMR application allows generic drug manufacturers to seek FDA approval for a modified-release version of an already-approved brand-name drug.
The SupACMR process involves demonstrating that the generic drug is therapeutically equivalent to the brand-name drug, meaning it has the same active ingredients, strength, dosage form, and route of administration. It must also demonstrate that the modified-release characteristics of the generic drug are equivalent to those of the brand-name drug.
To support the SupACMR application, the generic manufacturer provides data from various studies, such as in vitro release testing, pharmacokinetic studies, and comparative clinical trials. These data help the FDA assess the safety and effectiveness of the generic modified-release drug product.
Once approved, the generic modified-release drug product can be marketed as a lower-cost alternative to the brand-name drug, providing patients with more affordable access to important medications while maintaining the same therapeutic benefits.
