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 FTC 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 ...

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

YCANTH™’s listing in the Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is another feather in the cap for Verrica. The Orange Book is an ...

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 ...

EVITA attributes positive or negative rating points to the drug in question and its comparator in clinical trials by assessing both therapeutic benefit and risk profile, i.e. rate and strength of ...

Our confidence in our lead neuroscience asset is underpinned by its broad therapeutic potential across ... feedback on protocol from U.S. Food and Drug Administration (FDA). TRANQUILITY In-Care ...

The U.S. Food and Drug Administration (FDA) has approved a novel treatment that ... "Compared to TRAUMAGEL, these products are difficult to apply into wounds, as they must be packed physically ...

Bevespi Aerosphere (glycopyrrolate/formoterol fumarate) is a brand-name drug prescribed as a maintenance treatment for chronic obstructive pulmonary disease (COPD) in ...

Rocklatan (netarsudil/latanoprost ophthalmic solution) is prescribed to help reduce eye pressure in people with certain conditions. The drug can cause side effects ...

Tyrvaya (varenicline) is a prescription drug that’s used to treat dry eye disease in adults. The drug comes as a nasal spray. It’s typically used twice per day. Tyrvaya comes as a nasal spray ...

The Food and Drug Administration (FDA) approved Aimovig in 2018. So far, the drug hasn’t been known to cause any long-term side effects. If you develop serious side effects while using Aimovig ...