FDA RUSHES TO PLUG GAP ALLOWING GENERIC DRUGS TO BE DILUTED UNDER NEW RULES


From Endpoints News

In an effort to provide support for abbreviated new drug applications, the FDA on Thursday issued a flurry of product-specific recommendations, providing guidance for companies looking to develop generic versions of a number of popular medicines, including Mylan’s EpiPen (epinephrine) alternative Adrenaclick, Novartis’ cancer treatment Afinitor (everolimus) and AstraZeneca’s cancer treatment Lynparza (olaparib).

In total, new guidance was published for 32 drugs. On top of these new drafts, FDA released 19 revised guidance documents, including one for companies looking to develop generics of Eli Lilly’s erectile dysfunction drug Cialis, and other glaucoma treatments and antibiotics.

https://endpts.com/fda-releases-flurry-of-new-revised-drug-specific-guidance-documents/

“To successfully develop and manufacture a generic drug product, an applicant should consider that their  product is expected to be:  pharmaceutically equivalent to its reference listed drug (RLD), i.e., to have the same active ingredient, dosage form, strength, and route of administration under the same conditions of use,  bioequivalent to the RLD, i.e., to show no significant difference in the rate and extent of absorption of the active pharmaceutical ingredient;  and, consequently,  therapeutically equivalent, i.e., to be substitutable for the RLD with the expectation that the generic product will have the same safety and efficacy as its reference listed drug.”

https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm

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