Innovator companies should expect Orange Book patent listing challenges to emerge as an additional and simpler tool for ...

Teva’s asthma and COPD patents listed in the FDA’s Orange Book are under scrutiny and the company has until 24 July to adhere ...

[1] The warning letters sent to the pharmaceutical companies are part of the FTC’s new policy regarding listing of patents in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations ...

The investigation has been prompted by Teva’s refusal to take down about two dozen patents for its asthma and chronic obstructive pulmonary disorder (COPD) inhalers, according to a Washington Post ...

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 ...

According to "The Washington Post", the FTC claims that drug companies, among them Teva, made slight changes to their ...

These patents are listed in FDA's publication entitled Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. An NDA must be supported by studies ...

Relenza (zanamivir) is a brand-name drug that’s prescribed for the flu in adults and some children. Relenza comes as a powder that you inhale once or twice per day. The dosage can vary depending ...

Opzelura (ruxolitinib) is a prescription drug used to treat certain skin conditions, including eczema and vitiligo. Opzelura’s cost may depend on factors such as your dosage, whether you have ...

Myfembree (relugolix, estradiol, and norethindrone) is a brand-name drug that’s prescribed for specific symptoms related to uterine fibroids and endometriosis in certain adults. Myfembree comes ...

We want the best vet-approved food for our dogs so they live ... RELATED: 11 best dog and puppy products, per ‘Dog Whisperer’ Cesar Millan She suggested Royal Canin as an excellent choice ...