Content about SPRING

May 17, 2012
FDA approves generic versions of Plavix

The Food and Drug Administration has approved generic versions of one of the country's top-selling drugs made by eight different companies, the agency said Thursday.

May 16, 2012
FDA identifies three online products masquerading as dietary supplements

The Food and Drug Administration on Wednesday identified three online products touting "natural" intimacy enhancement that consumers should avoid because they each contain undeclared pharmaceutical ingredients.

May 4, 2012
New drug shortages cut in half as industry notifications increase

The number of new drug shortages has been halved as early notifications from manufacturers of potential shortages have increased sixfold, the commissioner of the Food and Drug Administration wrote Thursday.

April 27, 2012
FDA approves Vivus' Stendra for erectile dysfunction

The Food and Drug Administration has approved a new drug for treating erectile dysfunction, the agency said Friday.

April 24, 2012
FDA outlines global food, drug, device safety strategy

Globalization has led to a rapid increase in the drugs and foods arriving on U.S. shores from abroad, a trend that has prompted U.S. regulators to transform their approach.

April 3, 2012
FDA releases tobacco regulation draft guidance

The Food and Drug Administration on Friday released draft guidance that ultimately will provide the public with previously unknown information about the chemicals in tobacco products and help prevent misleading marketing about the risks associated with tobacco products, the agency said.

March 28, 2012
FDA approves Omontys for kidney disease-related anemia

The Food and Drug Administration has approved a new treatment for anemia in patients with chronic kidney disease.

March 26, 2012
Sunpeaks Ventures debuts TV spot for blood-thinner-friendly multivitamin

Sunpeaks Ventures last week announced national advertising support behind its Clotamin multivitamin line — a line of supplements formulated for use by patients on warfarin or other blood thinners.

March 22, 2012
FDA opens dialogue of incorporating technology, pharmacy into switch paradigm

The Food and Drug Administration's director of the Center for Drug Evaluation and Research, Janet Woodcock, on Thursday identified three tools the agency wanted to use in potentially increasing access to appropriate medicines in her opening remarks at the FDA Rx-to-OTC Switch Hearing.

March 22, 2012
GSK shares real-world example on how to improve switch through technology

GlaxoSmithKline on Thursday morning presented exactly how technology might improve appropriate patient self-selection before a panel convened by the Food and Drug Administration to explore expanding the prescripton-to-over-the-counter switch paradigm by incorporating technology and/or pharmacy participation in the application process.

March 19, 2012
FDA approves generic versions of osteoporosis drug

The Food and Drug Administration has approved the first generic version of a drug for treating and preventing osteoporosis in women after menopause, the agency said Monday.

March 8, 2012
FDA mulls over making some prescription drugs available over the counter

The Food and Drug Administration is looking at the possibility of selling certain prescription drugs over the counter under specific circumstances, the agency said.

March 1, 2012
FDA approves first flu vaccine to treat four strains of virus

The Food and Drug Administration has approved what it called the first flu vaccine to prevent four strains of the influenza virus.

March 1, 2012
FDA approves two new drugs for pancreatic disorders

The Food and Drug Administration has approved two new drugs for pancreatic disorders, the agency said Thursday.

February 28, 2012
FDA exploring how to expand eligible Rx-to-OTC switches by utilizing pharmacy

The Food and Drug Administration on Tuesday announced it will hold a public hearing on March 22 and 23 to discuss how technology can expand which drug products can be switched from prescription to over-the-counter status.

February 28, 2012
Statins could increase blood sugar, cause cognitive problems, FDA says

Drugs widely used to treat cholesterol may cause increases in blood sugar and other symptoms, the Food and Drug Administration said Tuesday.

February 23, 2012
FDA approves Korlym for Cushing's syndrome

The Food and Drug Administration has approved a drug for a rare disorder that previously had no approved medical therapies, the agency said.

February 21, 2012
FDA moves to address cancer drug shortages

An executive order from the Obama administration has spurred the Food and Drug Administration to address shortages of two cancer drugs and issue draft guidance for the industry to help prevent future shortages, the agency said Tuesday.

February 15, 2012
Counterfeit Avastin circulating in U.S., FDA warns

Fake versions of a cancer drug made by Roche's U.S. unit have entered the United States, the Food and Drug Administration warned Wednesday.

February 9, 2012
FDA issues warning on PPI, H2 blocker antacids: May increase risk of CDAD

The Food and Drug Administration on Wednesday issued a public warning that the use of proton-pump inhibitors or H2 blockers may be associated with an increased risk of Clostridium difficile–associated diarrhea, or CDAD.

February 9, 2012
FDA releases draft guidance for biosimilars

The Food and Drug Administration reached a major milestone on the path to a regulatory regime for follow-on biologics on Thursday with the release of draft guidance on biosimilar product development.

February 1, 2012
FDA approves new indication for Novartis' Gleevec

The Food and Drug Administration has approved a drug made by Novartis that is designed to prevent tumors in the gastrointestinal tract from recurring after surgical removal, the agency said.

January 31, 2012
FDA approves Vertex's Kalydeco for cystic fibrosis

The Food and Drug Administration has approved a drug made by Vertex Pharmaceuticals for treating a rare form of cystic fibrosis, the agency said Tuesday.

January 30, 2012
FDA approves Genentech skin cancer drug

The FDA announced the approval of Genentech's Erivedge (vismodegib) for adults with basal cell carcinoma who are not surgery or radiation therapy candidates and whose disease is locally advanced or has spread to other parts of the body.

January 27, 2012
FDA approves Pfizer's Inlyta for advanced kidney cancer

The Food and Drug Administration has approved a drug made by Pfizer for treating advanced kidney cancer, the agency said Friday.

© 2012 Drug Store News. All Rights Reserved.