The FDA produces "Approved Drug Products with Therapeutic Equivalence Evaluations", commonly referred to as the Orange Book. The Orange Book "identifies drug products approved on the basis of safety ...

Also known as Approved Drug Products with Therapeutic Equivalence Evaluations, the FDA’s Orange Book lists U.S.-approved treatments with their key details, including patent and exclusivity data.

The Orange Book – or Approved Drug Products with Therapeutic Equivalence Evaluations, as it is otherwise known – is a compendium of patents on drug substances, products, and methods of use ...

The agency warned in September that it may consider legal action against companies who list new patents in the Orange Book – or Approved Drug Products with Therapeutic Equivalence Evaluations ...

Officially titled the Approved Drug Products with Therapeutic Equivalence Evaluations, it is published by the US Food and Drug Administration (FDA) and provides a comprehensive list of approved ...

which is formally known as a compendium for the “Approved Drug Products with Therapeutic Equivalence Evaluations.” The Orange Book includes a list of safe and effective drug products that have ...

If a drug product is listed as discontinued in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book"), the manufacturer will also need to ask FDA if the drug ...

Planning initiation of SERENITY At-Home pivotal Phase 3 trial of BXCL501 for acute treatment of agitation associated with ...

Orladeyo (berotralstat) is a brand-name drug that’s prescribed to prevent attacks of hereditary angioedema (HAE) in adults and some children. Orladeyo comes as a capsule that’s taken by mouth ...