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 ...

Pressure is mounting in Congress and the regulatory agencies for changes to the drug patent system. Time will tell how fast ...

Drugmakers can avoid rival products, including lower-cost generics, for 30 months after listing a branded drug's patents in the "Orange Book," also known as "Approved Drug Products with ...

Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) and the release of its interim staff report on pharmacy benefit managers (PBMs). In the EU ...

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 ...

Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on reshaping vision possibilities, today ...

You may be able to get a 90-day supply of Plaquenil. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the ...

Femara (letrozole) is a prescription drug used to treat certain types of breast cancer in people who have gone through menopause. The drug comes as an oral tablet. Femara is not safe to take while ...

Levalbuterol and albuterol act quickly to open your airways during an asthma attack. Find out more about key differences and ...

Yupelri (revefenacin) is a brand-name medication prescribed for chronic obstructive pulmonary disease (COPD) in adults. As with other drugs, Yupelri can cause side effects, such as headache, cough ...

Klonopin (clonazepam) is a prescription drug used to treat panic disorder, agoraphobia, and certain seizure disorders. Klonopin comes as an oral tablet. It may not be safe to take this drug while ...