Content about Food and Drug Administration

May 31, 2011

The Food and Drug Administration has approved an injectable gel for fecal incontinence, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved an injectable gel for fecal incontinence, the agency said.

The FDA announced the approval of Oceana Therapeutics’ Solesta for patients who have involuntarily lost bowel control and for whom such therapies as diet change, fiber therapy and antimotility medications have failed.

Fecal incontinence affects more than 5.5 million Americans, according to the National Institutes of Health.

May 26, 2011

Eli Lilly is temporarily barred from using the same sales team to market two diabetes drugs, under a court order issued Thursday.

SAN DIEGO — Eli Lilly is temporarily barred from using the same sales team to market two diabetes drugs, under a court order issued Thursday.

May 26, 2011

A milk formula for babies made by Gerber Products can reduce the risk of atopic dermatitis, and Gerber has the Food and Drug Administration’s permission to say so.

FLORHAM PARK, N.J. — A milk formula for babies made by Gerber Products can reduce the risk of atopic dermatitis, and Gerber has the Food and Drug Administration’s permission to say so.

Gerber said Thursday that its Good Start milk-based formulas were the first and only infant formulas to meet the FDA’s criteria for a qualified health claim. The partially hydrolyzed formula may reduce a baby’s risk of developing atopic dermatitis in the first year.

May 25, 2011

The Food and Drug Administration sent 11 warning letters last week to online retailers selling tobacco products that claimed to reduce the harm and risk of tobacco-related disease.

SILVER SPRING, Md. — The Food and Drug Administration sent 11 warning letters last week to online retailers selling tobacco products that claimed to reduce the harm and risk of tobacco-related disease.

The FDA said Wednesday that the retailers had illegally marketed tobacco products that used such terms as “light,” “low,” “mild,” “less toxic” and “safer” — terms that the agency deems misleading and unsubstantiated.

May 25, 2011

Globe All Wellness on Tuesday recalled all lots of its Slim Xtreme herbal slimming capsule upon learning that the Food and Drug Administration determined the product contains the undeclared drug ingredient sibutramine.

HOLLYWOOD, Fla. — Globe All Wellness on Tuesday recalled all lots of its Slim Xtreme herbal slimming capsule upon learning that the Food and Drug Administration determined the product contains the undeclared drug ingredient sibutramine.

Sibutramine was the active ingredient in the prescription weight-loss drug Meridia, which had been pulled off the U.S. market due to increased risk of cardiovascular events or stroke.

May 24, 2011

Cuts to the Food and Drug Administration could be in the works, according to a published report.

NEW YORK — Cuts to the Food and Drug Administration could be in the works, according to a published report.

The Hill, a newspaper that covers Capitol Hill, reported Monday that the House Appropriations Committee suggested cutting the FDA’s budget by $285 million in its proposed 2012 spending bill, bringing its total budget for next year to $3.7 billion.

May 24, 2011

The Food and Drug Administration has approved a generic over-the-counter treatment for allergies made by Taro Pharmaceutical Industries.

HAWTHORNE, N.Y. — The Food and Drug Administration has approved a generic over-the-counter treatment for allergies made by Taro Pharmaceutical Industries.

Taro announced Monday the approval of cetirizine hydrochloride oral solution.

The drug, a generic version of Johnson & Johnson’s children’s Zyrtec, is used to relieve symptoms of indoor and outdoor allergies and is available in a sugar-free bubblegum flavor.

May 23, 2011

A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment.

BRIDGEWATER, N.J. — A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment.

Amneal Pharmaceuticals said that its nitrofurantoin oral suspension in the 25-mg/5-mL strength is the first-to-market, AB-rated, generic version of Furadantin, which is made by Shionogi Pharma.

Amneal will sell its generic in 8-oz./230-mL size bottles, the company said.

May 23, 2011

The Food and Drug Administration has approved a treatment for hepatitis C made by Vertex Pharmaceuticals, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for hepatitis C made by Vertex Pharmaceuticals, the agency said Monday.

The FDA approved Incivek (telaprevir) to treat adults with chronic hepatitis C infection, particularly those who either have not received interferon-based drug therapy or who have not responded to prior therapies. The drug is approved for use with therapies that include ribavirin and peginterferon alfa.

May 23, 2011

The Food and Drug Administration has approved a generic drug for epilepsy made by Mylan.

PITTSBURGH — The Food and Drug Administration has approved a generic drug for epilepsy made by Mylan.

Mylan said Monday that the FDA had approved its divalproex sodium capsules in the 125-mg strength. The drug is a generic version of Abbott’s Depakote Sprinkle capsules and is used to treat certain types of epileptic seizures.

Divalproex sodium capsules had sales of about $89 million during the 12-month period ended in March, according to IMS Health.

May 23, 2011

Generic drug maker Par has inked a definitive agreement to acquire an India-based developer and manufacturer of generic drugs.

WOODCLIFF LAKE, N.J. — Generic drug maker Par has inked a definitive agreement to acquire an India-based developer and manufacturer of generic drugs.

Par said it will acquire Edict Pharmaceuticals for up to $37.6 million in cash and Par's repayment of certain additional pre-close indebtedness. Par noted the acquisition is subject to customary conditions and approvals; the drug maker expects to complete the transaction by the end of the year.

May 23, 2011

The FDA has approved a new treatment for Type 2 diabetes, the agency said. The FDA announced the approval of Tradjenta (linagliptin) made by Indianapolis-based Eli Lilly and German drug maker Boehringer Ingelheim.


SUPPLIER NEWS — The FDA has approved a new treatment for Type 2 diabetes, the agency said. The FDA announced the approval of Tradjenta (linagliptin) made by Indianapolis-based Eli Lilly and German drug maker Boehringer Ingelheim.


May 23, 2011

The Food and Drug Administration has approved a Pfizer drug for treating pancreatic tumors.

NEW YORK — The Food and Drug Administration has approved a Pfizer drug for treating pancreatic tumors.

Pfizer announced Friday the approval of Sutent (sunitinib malate) for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in patients with locally advanced disease that can’t be removed through surgery. Pancreatic NET is a rare cancer reported in 2 million to 4 million people worldwide every year.

May 20, 2011

The Food and Drug Administration has approved a new antiretroviral treatment for HIV made by Johnson & Johnson, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new antiretroviral treatment for HIV made by Johnson & Johnson, the agency said Friday.

The FDA approved J&J subsidiary Tibotec Therapeutics’ Edurant (rilpivirine) as a treatment for use in combination with other HIV drugs in adults who have not been treated before.

May 20, 2011

A Food and Drug Administration advisory committee has voted to recommend that the FDA retain approval of an Abbott drug for high cholesterol in combination with a statin.

ABBOTT PARK, Ill. — A Food and Drug Administration advisory committee has voted to recommend that the FDA retain approval of an Abbott drug for high cholesterol in combination with a statin.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met Thursday to discuss whether to recommend continued FDA approval of Trilipix (fenofibric acid) in combination with simvastatin in patients with mixed dyslipidemia and a high risk of heart disease. The FDA is not bound by advisory committee votes, but usually follows them.

May 20, 2011

Sandoz is looking to market a generic version of a Shire drug for treating attention deficit hyperactivity disorder.

DUBLIN — Sandoz is looking to market a generic version of a Shire drug for treating attention deficit hyperactivity disorder.

May 19, 2011

Adflow Health Networks announced a large-scale deployment of its consumer health platform.

FORT WASHINGTON, Pa. — Adflow Health Networks announced a large-scale deployment of its consumer health platform.

Adflow Health Networks' Personal Health Center, an interactive digital media platform, provides consumers with access to trusted healthcare content and services, together with the ability to perform a wide range of Food and Drug Administration-cleared screenings, Adflow Health said. The full-scale deployment includes implementation across retail locations, worksites and high traffic areas.

May 19, 2011

A controversial GlaxoSmithKline drug for treating Type 2 diabetes no longer will be available through retail pharmacies as of Nov. 18, the Food and Drug Administration announced Wednesday.

SILVER SPRING, Md. — A controversial GlaxoSmithKline drug for treating Type 2 diabetes no longer will be available through retail pharmacies as of Nov. 18, the Food and Drug Administration announced Wednesday.

May 19, 2011

Two Food and Drug Administration advisory committees on Wednesday unanimously voted in favor of mandating weight-based dosing for children between the ages of 2 and 12 years who are being administered acetaminophen.

SILVER SPRING, Md. — Two Food and Drug Administration advisory committees on Wednesday unanimously voted in favor of mandating weight-based dosing for children between the ages of 2 and 12 years who are being administered acetaminophen.

May 17, 2011

The National Association of Chain Drug Stores delivered on Tuesday testimony on the safe usage of pediatric acetaminophen products before a joint meeting of the Food and Drug Administration Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores delivered on Tuesday testimony on the safe usage of pediatric acetaminophen products before a joint meeting of the Food and Drug Administration Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee.

May 17, 2011

A Food and Drug Administration panel will discuss findings in a clinical trial that has raised concerns about the safety and efficacy of Abbott's cholesterol-lowering drug when it’s combined with similar drugs, according to an FDA announcement.

SILVER SPRING, Md. — A Food and Drug Administration panel will discuss findings in a clinical trial that has raised concerns about the safety and efficacy of Abbott's cholesterol-lowering drug when it’s combined with similar drugs, according to an FDA announcement.

May 17, 2011

Perrigo on Monday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for over-the-counter ranitidine 150 (regular and cool mint), a generic version of Zantac 150.

ALLEGAN, Mich. — Perrigo on Monday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for over-the-counter ranitidine 150 (regular and cool mint), a generic version of Zantac 150.

Zantac 150 has annual sales of approximately $110 million, as measured by SymphonyIRI Group, Perrigo reported.

May 16, 2011

The Food and Drug Administration is convening its Nonprescription Drugs Advisory Committee Tuesday and Wednesday to debate mandating weight-based dosing for pediatric medicines containing acetaminophen on the Drug Facts label, as well as the potential expansion of dosing instructions to incorporate children under the age of 2 years old, according to material posted online by the FDA on Friday.

WASHINGTON — The Food and Drug Administration is convening its Nonprescription Drugs Advisory Committee Tuesday and Wednesday to debate mandating weight-based dosing for pediatric medicines containing acetaminophen on the Drug Facts label, as well as the potential expansion of dosing instructions to incorporate children under the age of 2 years old, according to material posted online by the FDA on Friday.

May 16, 2011

The Food and Drug Administration on Friday warned consumers about a counterfeit product represented as "ExtenZe," which is the name of an authentic dietary supplement for male sexual enhancement.

SILVER SPRING, Md. — The Food and Drug Administration on Friday warned consumers about a counterfeit product represented as "ExtenZe," which is the name of an authentic dietary supplement for male sexual enhancement.

The counterfeit product looks similar to the actual product, but either contains tadalafil, or a combination of tadalafil and sildenafil, all active ingredients in FDA-approved prescription medicines for erectile dysfunction.

May 16, 2011

Drug maker Mylan has launched a generic treatment for muscle spasms, the company said Friday.

PITTSBURGH — Drug maker Mylan has launched a generic treatment for muscle spasms, the company said Friday.

Mylan announced the launch of cyclobenzaprine hydrochloride, a once-daily muscle relaxant, in the 15-mg and 30-mg strengths. The drug is a generic version of Cephalon’s Amrix, which had sales of about $125 million during the 12-month period ended in March, according to IMS Health.