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August 15, 2012
Codeine increases risk of death in some children, FDA warns

Children who take a class of opioid pain relievers after certain surgeries may be at risk of death, the Food and Drug Administration warned Wednesday.

SILVER SPRING, Md. — Children who take a class of opioid pain relievers after certain surgeries may be at risk of death, the Food and Drug Administration warned Wednesday.

The FDA issued the warning after receiving reports of three children who died and one who experienced a life-threatening case of respiratory depression after taking codeine following tonsil- and adenoid-removal surgery.

August 14, 2012
FDA approves formulation for 2012-2013 flu vaccines

The Food and Drug Administration has approved the formulation for the 2012-2013 flu vaccine, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved the formulation for the 2012-2013 flu vaccine, the agency said Monday.

The agency's approval is for all six licensed flu vaccines for the 2012-2013 season: Afluria, made by CSL; Fluarix, made by GlaxoSmithKline; FluLaval, made by ID Biomedical; FluMist, made by MedImmune Vaccines; Fluvirin, made by Novartis; and Fluzone, made by Sanofi.

August 13, 2012
FDA approves Genentech's Lucentis for diabetic macular edema

Regulators have approved a biotech drug made by Genentech for treating a complication related to diabetes.

SILVER SPRING, Md. — Regulators have approved a biotech drug made by Genentech for treating a complication related to diabetes.

The Food and Drug Administration approved Lucentis (ranibizumab) for diabetic macular edema, a cause of vision loss in people with diabetes. The drug already was approved for age-related macular degeneration.

August 9, 2012
FDA approves new leukemia drug

The Food and Drug Administration has approved a new drug for treating a rare type of leukemia, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare type of leukemia, the agency said Thursday.

The FDA approved South San Francisco, Calif.-based Talon Therapeutics' Marqibo (vincristine sulfate liposome), an injectable drug for Philadelphia chromosome-negative acute lymphoblasic leukemia, or Ph-negative ALL.

August 6, 2012
FDA approves generic versions of asthma, allergy drug

The Food and Drug Administration has approved several generic versions of a drug used to treat asthma and allergies, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved several generic versions of a drug used to treat asthma and allergies, the agency said Friday.

The FDA announced the approval of montelukast sodium, a drug indicated for controlling asthma symptoms and relieving indoor and outdoor allergies.

The drug is a generic version of Merck's Singulair, which had sales of $4.6 billion in 2011, according to IMS Health.

August 6, 2012
FDA approves Sanofi drug for colorectal cancer

The Food and Drug Administration has approved a new drug for treating colorectal cancer that has spread to other parts of the body, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating colorectal cancer that has spread to other parts of the body, the agency said Friday.

July 27, 2012
FDA panel recommends new approval for Genentech eye drug

A panel of Food and Drug Administration experts is recommending the approval of a drug made by Genentech for diabetic macular edema, the company said.

SILVER SPRING, Md. — A panel of Food and Drug Administration experts is recommending the approval of a drug made by Genentech for diabetic macular edema, the company said.

July 24, 2012
FDA approves new COPD drug

The Food and Drug Administration has approved a new drug made by Forest Labs for treating chronic obstructive pulmonary disease, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Forest Labs for treating chronic obstructive pulmonary disease, the agency said.

The FDA announced the approval of Tudorza Pressair (aclidinium bromide) for the long-term maintenance of COPD-related narrowing of the airways in the lung, also known as bronchospasm. The drug is an inhaled dry powder used twice per day.

July 23, 2012
FDA approves blood cancer drug

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

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating multiple myeloma, the agency said Friday.

July 18, 2012
FDA approves weight-loss drug

The Food and Drug Administration has approved a new weight-loss drug made by Vivus, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new weight-loss drug made by Vivus, the agency said.

The FDA announced the approval of Qsymia (phentermine and topiramate) extended-release, designed for use by overweight and obese adults alongside a reduced-calorie diet and exercise for chronic weight management. The drug's original brand name was Qnexa.

July 16, 2012
Gilead's Truvada approved for PrEP

The Food and Drug Administration has approved a drug used to treat HIV for reducing the risk of HIV infection, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug used to treat HIV for reducing the risk of HIV infection, the agency said Monday.

July 13, 2012
FDA appoints new generic drugs office head

The main office of the Food and Drug Administration in charge of regulating generic drugs has appointed a new director, the agency said Friday.

SILVER SPRING, Md. — The main office of the Food and Drug Administration in charge of regulating generic drugs has appointed a new director, the agency said Friday.

The FDA announced the appointment of Gregory Geba as director of the Office of Generic Drugs, replacing acting director Keith Webber, effective Sunday.

Geba has served in various senior-level clinical and managerial positions in the drug industry for the past 15 years, most recently as deputy chief medical officer for Sanofi US, a subsidiary of French drug maker Sanofi.

July 5, 2012
FDA orders unapproved oxycodone drugs off market

The Food and Drug Administration is asking companies to stop manufacturing and distributing unapproved drugs containing the painkiller oxycodone, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration is asking companies to stop manufacturing and distributing unapproved drugs containing the painkiller oxycodone, the agency said Thursday.

July 3, 2012
FDA approves OTC HIV test

The Food and Drug Administration has approved over-the-counter sales of a test for the virus that causes AIDS, the agency said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved over-the-counter sales of a test for the virus that causes AIDS, the agency said Tuesday.

The FDA announced the approval of the OraQuick In-Home HIV Test, calling it the first OTC, self-administered HIV test kit that detects the presence of antibodies to HIV, including the HIV-1 and HIV-2 strains.

June 28, 2012
FDA approves overactive bladder drug made by Astellas

The Food and Drug Administration has approved a new drug for treating overactive bladder made by Astellas Pharma, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating overactive bladder made by Astellas Pharma, the agency said Thursday.

The FDA announced the approval of Myrbetriq (mirabegron), which works by relaxing the bladder muscle while the organ is filling. In patients with overactive bladder, the muscle can't be controlled, squeezes too often or squeezes without warning. Symptoms of overactive bladder include the need to urinate too often, the need to urinate immediately and incontinence. The condition affects about 33 million Americans.

June 27, 2012
FDA approves new obesity drug

The Food and Drug Administration has approved a new treatment for obesity in adults, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for obesity in adults, the agency said Wednesday.

The FDA announced the approval of Arena Pharmaceuticals' Belviq (lorcaserin hydrochloride), designed for use alongside reduced-calorie diets and exercise, for chronic weight management. Eisai will distribute the drug.

May 31, 2012
FDA warns parents on using benzocaine to relieve pain of teething babies

The Food and Drug Administration on Thursday warned parents against administering benzocaine to their teething babies and advised that parents not use benzocaine at all in children under the age of 2 years unless under the supervision of a family physician.

SILVER SPRING, Md. — The Food and Drug Administration on Thursday warned parents against administering benzocaine to their teething babies and advised that parents not use benzocaine at all in children under the age of 2 years unless under the supervision of a family physician.

May 30, 2012
FDA warns consumers, healthcare professionals about fake Adderall

A counterfeit version of a Teva Pharmaceutical Industries attention deficit hyperactivity disorder and narcolepsy drug is circulating online, regulators warned Tuesday.

SILVER SPRING, Md. — A counterfeit version of a Teva Pharmaceutical Industries attention deficit hyperactivity disorder and narcolepsy drug is circulating online, regulators warned Tuesday.

The Food and Drug Administration issued a statement warning consumers and healthcare professionals that a fake versions of Adderall (dextroamphetamine and amphetamine) tablets in the 30-mg strength are being sold on the Internet.

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.

SILVER SPRING, Md. — 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.

SILVER SPRING, Md. — 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.

The three products include Boost ultra sexual enhancement formula, VMaxx Rx and Firminite.

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.

SILVER SPRING, Md. — 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.

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

The FDA announced the approval of Vivus' Stendra (avanafil).

"This approval expands the available treatment options to men experiencing erectile dysfunction and enables patients, in consultation with their doctor, to choose the most appropriate treatment for their needs," FDA Office of Drug Evaluation III deputy director Victoria Kusiak said.

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.

SILVER SPRING, Md. — 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.

The Food and Drug Administration released a report Monday detailing its strategies for what it called transforming from a domestic to a global public health agency.

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.

SILVER SPRING, Md. — 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.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for anemia in patients with chronic kidney disease.

The FDA announced the approval of Affymax's Omontys (peginesatide), a drug belonging to the class known as erythropoiesis-stimulating agents, designed to aid the formation of red blood cells.