Content about FDA

December 10, 2012

Astellas Pharma US has announced the Food and Drug Administration's approval to review the new drug application for tacrolimus extended-release capsules.

NORTHBROOK, Ill. — Astellas Pharma US announced the Food and Drug Administration's review of their new drug application for tacrolimus extended-release capsules, a once-daily formulation of the calcineurin-inhibitor immunosuppressant tacrolimus, for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients.

December 5, 2012

Tria Beauty has announced its partnership with actress Jenny McCarthy on behalf of its Tria Hair Removal Laser, the FDA-cleared laser available for at-home hair removal.

DUBLIN, Calif. —Tria Beauty has announced its partnership with actress Jenny McCarthy on behalf of its Tria Hair Removal Laser, the FDA-cleared laser available for at-home hair removal.  

Under this new partnership, McCarthy will be collaborating with Tria for various public relations and marketing campaigns. 

November 15, 2012

The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.


FDA approves Par leukemia drug
WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.


Par said Oct. 25 that the FDA had approved Anchen Pharmaceuticals’ tretinoin capsules in the 10-mg strength.


The drug is a generic version of Roche’s Vesanoid, various versions of which have annual sales of about $29 million, according to IMS Health.



 

November 13, 2012

Health warning labels on cigarette packages that use pictures to show the health consequences of smoking are effective in reaching adult smokers, according to the results of a new study published in the December issue of the American Journal of Preventive Medicine.

SAN DIEGO — Health warning labels on cigarette packages that use pictures to show the health consequences of smoking are effective in reaching adult smokers, according to the results of a new study published in the December issue of the American Journal of Preventive Medicine

November 5, 2012

The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain.

FDA approves cardiovascular drug

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain. Actavis announced the approval of diltiazem hydrochloride extended-release capsules.
The drug is a generic version of Valeant’s Tiazac. The branded drug and its generic equivalents had sales of about $76.3 million in 2011, according to IMS Health.



October 18, 2012

The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said Thursday.

MUMBAI, India — The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said Thursday.

Lupin announced the approval of Kurvelo (levonorgestrel and ethinyl estradiol) tablets in the 0.15 mg/0.03 mg strength.

The drug is a generic version of Teva's branded Nordette. Nordette had sales of about $59 million during the 12-month period ended in June, according to IMS Health.

October 18, 2012

SoloHealth on Thursday announced it has plans in place to expand its FDA-approved SoloHealth Station health-and-wellness digital kiosks to more than 2,500 store locations by mid-2013, scaling to more than 4,000 by 2014.

ATLANTA, Ga. — SoloHealth on Thursday announced it has plans in place to expand its FDA-approved SoloHealth Station health-and-wellness digital kiosks to more than 2,500 store locations by mid-2013, scaling to more than 4,000 by 2014. 

October 17, 2012

Gojo Industries on Wednesday announced the results of a series of independent lab studies testing the ability of instant hand sanitizers to meet Food and Drug Administration Healthcare Personnel Handwash germ kill requirements at various dosage levels.

AKRON, Ohio — Gojo Industries on Wednesday announced the results of a series of independent lab studies testing the ability of instant hand sanitizers to meet Food and Drug Administration Healthcare Personnel Handwash germ kill requirements at various dosage levels. The studies, which included more than 20 different hand sanitizers, concluded that the patent-pending Purell Advanced Instant Hand Sanitizer formulation is the only one to meet FDA germ kill requirements with a single 1.2-mL dispense.

October 5, 2012

What if Moore's law — meaning the number of transistors per square inch on integrated circuits would double every two years — applied to healthcare applications?

WHAT IT MEANS AND WHY IT'S IMPORTANT — What if Moore's law — meaning the number of transistors per square inch on integrated circuits would double every two years — applied to healthcare applications? That actually was all the talk earlier this year at the TedMed conference, at least according to a blog written by Dave Copeland, a well-vetted business and technology journalist.

September 24, 2012

The Food and Drug Administration is creating a new task force to support the development of new drugs for bacterial infections, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration is creating a new task force to support the development of new drugs for bacterial infections, the agency said Monday.

The FDA said the Antibacterial Drug Development Task Force would assist in developing and revising guidance related to development of antibiotics, as required by the Generating Antibiotic Incentives Now Title of the FDA Safety and Innovation Act, which president Barack Obama signed into law on July 9.

August 27, 2012

Pharmacy is in a state of deep transformation, but it could take some time for the trend to gain traction.

DENVER – Pharmacy is in a state of deep transformation, but it could take some time for the trend to gain traction.

August 17, 2012

The September 2012 issue of Consumer Reports revealed that the dietary supplement industry still has a tough road to hoe in distancing responsible players in the nutritional sector from those purveyors of illegally marketed drugs and other quackery products. 


The September 2012 issue of Consumer Reports revealed that the dietary supplement industry still has a tough road to hoe in distancing responsible players in the nutritional sector from those purveyors of illegally marketed drugs and other quackery products. 


August 3, 2012

SoloHealth on Friday announced a new relationship with WellPoint to help provide consumers with convenient access to information about their health and wellness through the next-generation SoloHealth Station consumer kiosks.

ATLANTA — SoloHealth on Friday announced a new relationship with WellPoint to help provide consumers with convenient access to information about their health and wellness through the next-generation SoloHealth Station consumer kiosks.

The news comes on the heels of SoloHealth's recent FDA approval in June, as well as its announcement of an aggressive rollout to retail locations nationwide to begin this fall.

July 6, 2012

The sweeping healthcare reforms encompassed in the landmark Patient Protection and Affordable Care Act will transform parts of the American healthcare landscape. But the nation’s fiscal challenges and the unsustainable cost increases generated by the U.S. health system also will drive fundamental changes in the way providers, payers and patients search for a more cost-effective and accountable set of solutions to a health system in crisis, said McKesson’s top public policy expert at ideaShare 2012.

LAS VEGAS — The sweeping healthcare reforms encompassed in the landmark Patient Protection and Affordable Care Act will transform parts of the American healthcare landscape. But the nation’s fiscal challenges and the unsustainable cost increases generated by the U.S. health system also will drive fundamental changes in the way providers, payers and patients search for a more cost-effective and accountable set of solutions to a health system in crisis, said McKesson’s top public policy expert at ideaShare 2012.

July 5, 2012

Actavis has received a preliminary approval for a generic drug for treating high blood pressure, the drug maker said Thursday.

MORRISTOWN, N.J. — Actavis has received a preliminary approval for a generic drug for treating high blood pressure, the drug maker said Thursday.

May 29, 2012

Dietary supplement industry champion Sen. Orrin Hatch, R-Utah, last week led efforts to strike down an amendment that would have dramatically overregulated the dietary supplement industry.

WASHINGTON — Dietary supplement industry champion Sen. Orrin Hatch, R-Utah, last week led efforts to strike down an amendment that would have dramatically overregulated the dietary supplement industry.

May 24, 2012

The $317 billion problem of medication nonadherence has many sources that often combine and overlap in complex ways. But fears of whether a drug is safe and will work are among of the most frequently cited reasons why patients don't take their drugs as prescribed, or don't take them at all.

WHAT IT MEANS AND WHY IT'S IMPORTANT — The $317 billion problem of medication nonadherence has many sources that often combine and overlap in complex ways. But fears of whether a drug is safe and will work are among of the most frequently cited reasons why patients don't take their drugs as prescribed, or don't take them at all.

May 14, 2012

Grooming products company Remington and software development firm Kadro Solutions have announced the release of the i-Light Pro mobile application for iPhone, Android and iPad, in conjunction with the U.S. release of Remington i-Light Pro Intense Pulsed Light hair removal system.

MADISON, Wis., and RALEIGH, N.C. — Grooming products company Remington and software development firm Kadro Solutions have announced the release of the i-Light Pro mobile application for iPhone, Android and iPad, in conjunction with the U.S. release of Remington i-Light Pro Intense Pulsed Light hair removal system.

April 20, 2012

Clerisy on Thursday announced its nasal delivery system Nasal SoftStrips, designed to administer over-the-counter medicants or therapeutic vapors, now will be available in 71 Wegmans stores in the grocer's Nature's Marketplace section.

ROCHESTER, N.Y. — Clerisy on Thursday announced its nasal delivery system Nasal SoftStrips, designed to administer over-the-counter medicants or therapeutic vapors, now will be available in 71 Wegmans stores in the grocer's Nature's Marketplace section.

According to the company, Nasal SoftStrips delivery system is a patented and FDA-approved medical device designed to deliver health-benefitting concentrated therapeutic vapors through the nasal system, without the use of sprays or powders.

April 13, 2012

With the help of YouTube and Facebook, several beauty and personal care companies are proving that Internet marketing can indeed be quite successful.

With the help of YouTube and Facebook, several beauty and personal care companies are proving that Internet marketing can indeed be quite successful. One prime example is Orabrush, which makes an FDA-approved tongue cleaner. Through a series of YouTube videos, Orabrush went from an online-only offering to now being sold in 20,000 drug stores, supermarkets, discount stores and supercenters.


March 26, 2012

A drug under development by Forest Labs and Pierre Fabre has been shown to reduce symptoms of major depressive disorder, the companies said.

SUPPLIER NEWS — A drug under development by Forest Labs and Pierre Fabre has been shown to reduce symptoms of major depressive disorder, the companies said. New York-based Forest and Paris-based Pierre Fabre announced results of a phase-3 trial of levomilnacipran, saying the drug showed reductions in symptoms as early as one week after treatment was started. The companies expect results of another phase-3 trial of the drug this spring.


 

March 8, 2012

Written testimony submitted by the National Association of Chain Drug Stores underscored chain pharmacies’ commitment to patient safety as part of the next Prescription Drug User Fee Act reauthorization, and emphasized that community pharmacist-provided services help improve health outcomes without the introduction of unproven technologies.

ALEXANDRIA, Va. — Written testimony submitted by the National Association of Chain Drug Stores underscored chain pharmacies’ commitment to patient safety as part of the next Prescription Drug User Fee Act reauthorization, and emphasized that community pharmacist-provided services help improve health outcomes without the introduction of unproven technologies.

February 22, 2012

Psi Bands on Wednesday announced its line of fashionable nausea-relief bands was recently recognized with Kimberly Clark's Huggies MomInspired Grant, a grant program designed to recognize and support inspirational and entrepreneurial moms.

PACIFIC GROVE, Calif. — Psi Bands on Wednesday announced its line of fashionable nausea-relief bands recently was recognized with Kimberly-Clark's Huggies MomInspired Grant, a grant program designed to recognize and support inspirational and entrepreneurial moms.

February 16, 2012

A study published in the November 2011 International Journal of Food Sciences and Nutrition demonstrated a nearly 5% reduction in “bad” low-density lipoprotein cholesterol when Pharmavite's CholestOff was added to the National Cholesterol Education Program therapeutic lifestyle changes diet, Pharmavite announced Wednesday.

NORTHRIDGE, Calif. — A study published in the November 2011 International Journal of Food Sciences and Nutrition demonstrated a nearly 5% reduction in “bad” low-density lipoprotein cholesterol when Pharmavite's CholestOff was added to the National Cholesterol Education Program therapeutic lifestyle changes diet, Pharmavite announced Wednesday.

February 15, 2012

The Coppertone Solar Research Center has announced the launch of two new product lines: Coppertone Sport Pro Series and Coppertone Wet ‘n Clear.

MEMPHIS, Tenn. — The Coppertone Solar Research Center has announced the launch of two new product lines: Coppertone Sport Pro Series and Coppertone Wet ‘n Clear.

The new Coppertone Sport Pro Series sunscreens are designed to help protect sports enthusiasts from the damaging effects of the sun, while not compromising skin’s natural hydration. The new Coppertone Wet ‘n Clear line offers families sun protection that cuts through water without needing to towel dry, while also helping to keep skin moisturized.