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Over the past two decades

Many Drugs Made Available Via FDA Expanded Access Programs

Half of meds ID'd in expanded access programs treat cancer; others for metabolic, endocrine diseases
The first generic version of an under-the-tongue film to treat opioid addiction has been approved by the U.S. Food and Drug Administration.

FDA Approves First Generic Under-the-Tongue Suboxone

May only be prescribed by Drug Addiction Treatment Act-certified prescribers
Nine online networks

FDA Warns Websites Marketing Unapproved Opioids

As part of comprehensive effort to target online sales, networks operating 53 sites received warnings
The first biosimilar drug to Neulasta has been approved by the U.S. Food and Drug Administration. Fulphila (pegfilgrastim) is approved for patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy and have symptoms of febrile neutropenia.

FDA OKs 1st Biosimilar to Prevent Chemo-Related Infections

Fulphila, biosimilar to Neulasta, helps reduce risk of infection during cancer treatment
The first artificial iris has been approved by the U.S. Food and Drug Administration for patients with aniridia.

FDA Approves First Artificial Iris

CustomFlex Artificial Iris improves light sensitivity and glare, cosmetic appearance of the eye
U.S. Food and Drug Administration approval of Xeljanz (tofacitinib) has been expanded to include adults with active moderate-to-severe ulcerative colitis

FDA Approves New Treatment for Ulcerative Colitis

First oral medication approved for chronic use in moderate-to-severe active ulcerative colitis
Palynziq (pegvaliase-pqpz) has been approved by the U.S. Food and Drug Administration to treat phenylketonuria

FDA Approves Palynziq for Phenylketonuria

Drug is a novel enzyme therapy for adult patients with PKU with uncontrolled blood Phe concentrations
Aimovig (erenumab-aooe) has been approved by the U.S. Food and Drug Administration to prevent migraine headaches in adults.

FDA Approves Aimovig to Prevent Migraines

Patients taking Aimovig reported one to two fewer monthly migraine days than those taking pacebo
Doptelet (avatrombopag) has been approved by the U.S. Food and Drug Administration to treat adults with chronic liver disease who are slated to have a medical or dental procedure.

FDA OKs Doptelet for Liver Dz Patients Undergoing Procedures

Doptelet reduces the need for platelet transfusion or any rescue therapy on day of procedure
Lucemyra (lofexidine hydrochloride) has been approved by the U.S. Food and Drug Administration to treat symptoms of opioid withdrawal.

FDA Approves Non-Opioid Treatment for Opioid Withdrawal

Lucemyra is an oral selective alpha 2-adrenergic receptor agonist