The FDA Has Released New Generic Drug-Specific Recommendations

Sixty-seven generic drug-specific recommendations have been released by the U.S. Food and Drug Administration (FDA). There are 33 revised ones and 34 new ones. These describe what expectations the agency has for the development of generics that are equivalent in therapeutic terms to drugs that are reference-listed.


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The guidance provided by the FDA is there to help those in the pharmaceutical industry to identify the best ways of generating the evidence they need to support their Abbreviated New Drug Application (ANDA) approval.

Third Release

This is the third release in 2016 that the FDA has provided for generic drug developers to give them revised and new bioequivalence guidance. In January, 11 products were revised and 31 draft recommendations were released, whilst in June, 19 revisions were made and 19 new draft documents were introduced.

All of the guidance provided to pharmaceutical companies helps to answer questions such as how long does it take to get a FDA 510k approved, with companies such as assisting them.

New Products

Before they finalize the 33 revisions and the draft bioequivalence (BE) guidance, the FDA are waiting for feedback.

Some of the new products they are focusing on are: Acetaminophen (Oxycodone hydrochloride), also known as Percocet; this is a pain reliever; Alectinib hydrochloride, produced by Genentech as a treatment for lung cancer; Betamethasone dipropionate, a skin ointment; Cholic acid, an approved treatment of bile acid synthesis disorders; Clobetasol propionate, a medication for treating psoriasis; Crotamiton, which can be used to treat severe itching or scabies; Desonide, a treatment for some skin problems, including dermatitis; Dexlansoprazole, a heartburn treatment; Pyrazinamide, a treatment for tuberculosis; Prochlorperazine, which helps to treat schizophrenia, anxiety, vomiting or nausea; Morphine sulfate, a treatment for pain; and Ibuprofen.

ANDA applicants are advised by the FDA that when they’re trying to develop a generic drug and manufacture it, they should ensure that their product meets a number of criteria. This includes making sure it’s equivalent to its RLD (i.e. it has the same strength, dosage form, active ingredient and is administrated under the same conditions); that it’s bioequivalent to the RLD (i.e. it isn’t significantly different in how much and how quickly the active pharmaceutical ingredient is absorbed; and it is therapeutically equivalent (i.e. it is as safe and efficient as the reference-listed drug it is substituting).