Advertisement
Home Tags Food & Drug Administration

Tag: Food & Drug Administration

A proposal for identifying lower-cost generic biotech drugs has been released by the U.S. Food and Drug Administration.

FDA Issues Proposal on Lower-Cost, Generic Biotech Drugs

0
All biotech drugs to carry a four-letter code to distinguish brand name, generic versions
U.S. Food and Drug Administration approval of the drug Promacta (eltrombopag) has been expanded to include children 1 year and older with chronic immune thrombocytopenic purpura.

Promacta Approval Expanded for Children With Chronic ITP

0
Builds on recent approval for ages 6 years and up for chronic immune thrombocytopenic purpura
Addyi (flibanserin) has been approved by the U.S. Food and Drug Administration as the first drug to treat generalized hypoactive sexual desire disorder among premenopausal women. The drug is for women who do not have an underlying physical or psychological cause for the disorder

FDA Approves Libido Pill for Women

0
Addyi to treat generalized hypoactive sexual desire disorder among premenopausal women
New violations by the maker of medical scopes recently linked to deadly infections in patients have been discovered by the U.S. Food and Drug Administration.

FDA Reveals More Violations by Medical Scope Maker

0
Infections in patients who underwent procedures with Olympus scopes in 2012 went unreported
The age of 3D printing has come to the drug industry

FDA Approves First 3D Printed Prescription Medication

0
Epilepsy drug Spritam may be one of many custom-made medicines to come that will use the technology
The ReShape Integrated Dual Balloon System has been approved by the U.S. Food and Drug Administration to combat adult obesity. Inflated inside the stomach

FDA Approves Balloon Device to Treat Obesity

0
Inflated in stomach, it may create sense of fullness
Praluent (alirocumab) injection has been approved by the U.S. Food and Drug Administration for use in addition to diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease

FDA Approves Praluent for Certain Cases of High Cholesterol

0
First in a new class of injectable cholesterol-lowering medications
About 10 percent of cases where a drug does serious harm are not reported to the U.S. Food and Drug Administration within the required 15-day period

Delays Noted in the Reporting of Serious Patient Harms to FDA

0
Analysis found roughly 10 percent of cases were filed after 15-day deadline passed
A new diagnostic to differentiate between HIV-1 antibodies

FDA Approves Test to Differentiate HIV Viruses

0
Among people two years and older
Technivie (ombitasvir

FDA Approves Technivie for Hepatitis C

0
For people with chronic hepatitis C genotype 4