PubChem

May 16, 2018, The U.S. Food and Drug Administration today approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. While Lucemyra may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment for up to 14 days. Lucemyra is not a treatment for opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD.

Akynzeo is a compound intravenous injection of the 5-HT3 receptor antagonist palonosetron and the NK-1 receptor antagonist fosnetupitant to prevent nausea and vomiting in chemotherapy patients with cancer.
Palonosetron was approved in 2008 for the prevention of nausea and vomiting in the acute phase (within 24 hours) after the start of cancer chemotherapy. Fosnetupitant is a new drug used to prevent nausea and vomiting in the acute and delayed phases (25 hours to 120 hours after chemotherapy) after cancer chemotherapy begins.

What is the drug for?

ILUMYA is a drug for treatment of moderate to severe plaque psoriasis, in adults, who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

What is the drug for?

SYMDEKO is a drug for the treatment of cystic fibrosis (CF) in patients 12 years and older, who have specific gene mutations.

CF is a serious genetic disorder that results in the formation of thick mucus that builds up in the lungs and other parts of the body. This can lead to severe breathing problems.

What is the drug for?

BIKTARVY is a drug for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults. BIKTARVY is a combination of three antiviral drugs in a single tablet: bictegravir (new drug for HIV-1 treatment), emtricitabine, and tenofovir alafenamide (previously approved for HIV-1 treatment).

HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

January 26, 2018, The U.S. Food and Drug Administration today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult patients with somatostatin receptor-positive GEP-NETs.

On April 17, 2018, the Food and Drug Administration approved fostamatinib disodium hexahydrate tablets (TAVALISSE, Rigel Pharmaceuticals, Inc.) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

On February 14, 2018, the Food and Drug Administration approved apalutamide (Erleada™, Janssen Biotech, Inc.) for patients with non-metastatic castration-resistant prostate cancer (NM-CRPC).

Approval was based on a multicenter, double-blind, clinical trial (SPARTAN, NCT01946204) randomizing 1,207 patients with NM-CRPC (2:1) to receive either apalutamide, 240 mg orally once daily in combination with ADT (medical castration or surgical castration) (n=806), or placebo once daily with ADT (n=401).

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

This page summarizes news about Novel Drug and Active Ingredients approved by FDA in 2018.