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Pharmaceuticals / Regulatory Affairs

FDA Issues 63 New Product-Specific Guidances for Generic Drugmakers

Dec. 6, 2018
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The FDA released 63 product-specific guidances for generic drugmakers, including 43 for drugs with no generics currently on the market.

The new batch includes guidelines for developing generics for Shire’s dry eye drug Xiidra (lifitegrast) and three diabetes drugs manufactured by Merck, Seglatro (ertugliflozin) , Steglujan (ertugliflozin )and Segluromet (ertugliflozin and metformin).

“By issuing recommendations on how to develop products that are therapeutically equivalent to these branded drugs, we’re making the process for copying these medicines more efficient and creating an easier path for generic alternatives to enter the market,” said FDA Commissioner Scott Gottlieb.

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