USA – New Product-Specific Guidances Focus on Drugs Without Generic Competition

The US Food and Drug Administration (FDA) on Tuesday issued 63 new and revised draft product-specific guidances detailing its expectations for companies looking to develop generic versions of those products.

Of the 63 guidances, 22 are new draft guidances and 41 are revised draft guidances. According to FDA Commissioner Scott Gottlieb, nearly 70% (43) of the guidances are for products that do not have any generic competition.

Some of the newly released draft guidances include product-specific recommendations for developing generic versions of Shire’s dry eye drug Xiidra (lifitegrast) and Merck’s type 2 diabetes drugs Steglatro (ertugliflozin), Steglujan (ertugliflozin and sitagliptin) and Segluromet (ertugliflozin and metformin HCI).

The latest batch of product-specific guidances also brings the total issued by the agency to more than 1,600 since it began releasing the guidances in 2007…