Content about FDA

November 19, 2012

The year 2012 is coming to an end, and it's been a big year for generic drugs. It's the year that the most lucrative drug of all time became commoditized. It's the year that Watson bought Actavis for $5.6 billion. And it's the year the FDA released draft guidance for biosimilars regulations. All of these events speak to some of the most important trends in the world of generics — trends that are often interrelated.

The year 2012 is coming to an end, and it's been a big year for generic drugs. It's the year that the most lucrative drug of all time became commoditized. It's the year that Watson bought Actavis for $5.6 billion. And it's the year the FDA released draft guidance for biosimilars regulations. All of these events speak to some of the most important trends in the world of generics — trends that are often interrelated.

 

April 14, 2014

Stayhealthy has announced the completion of its deployment of 765 Stayhealthy HealthCenter Kiosks throughout Albertson’s LLC and New Albertson’s Inc.

MONROVIA, Calif. — Stayhealthy has announced the completion of its deployment of 765 Stayhealthy HealthCenter Kiosks throughout Albertson’s LLC and New Albertson’s Inc.

April 8, 2014

Diplomat on Monday announced that it is one of a select group of specialty pharmacies contracted by Celgene to distribute Otezla (apremilast), a new medication for the treatment of psoriatic arthritis.

FLINT, Mich. — Diplomat on Monday announced that it is one of a select group of specialty pharmacies contracted by Celgene to distribute Otezla (apremilast), a new medication for the treatment of psoriatic arthritis. Otezla is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). 

Otezla was approved by the FDA on March 21, 2014, and is available in 10 mg, 20 mg and 30 mg tablets. 

April 8, 2014

Healthcare Distribution Management Association president and CEO John Gray on Monday testified before the House Energy and Commerce Subcommittee on Health at a hearing on “Improving Predictability and Transparency in DEA and FDA Regulation.”

ARLINGTON, Va. — Healthcare Distribution Management Association president and CEO John Gray on Monday testified before the House Energy and Commerce Subcommittee on Health at a hearing on “Improving Predictability and Transparency in DEA and FDA Regulation.” HDMA is in support of the Ensuring Patient Access and Effective Drug Enforcement Act of 2014, H.R. 4069, sponsored by Reps. Marino, R-Pa., and Blackburn, R-Tenn. 

April 7, 2014

The National Association of Chain Drug Stores submitted a written statement in lead-up to Monday’s hearing of the U.S. House Committee on Energy and Commerce Subcommittee on Health urging transparency in how federal agencies conduct enforcement activities to help curb prescription drug diversion and abuse.

ARLINGTON, Va. — The National Association of Chain Drug Stores submitted a written statement in lead-up to Monday’s hearing of the U.S. House Committee on Energy and Commerce Subcommittee on Health urging transparency in how federal agencies conduct enforcement activities to help curb prescription drug diversion and abuse.

The hearing is titled “Improving Predictability and Transparency in DEA and FDA Regulation.”  

April 2, 2014

Stayhealthy announced the completion of its deployment of Stayhealthy HealthCENTER Kiosks in six states throughout the Supervalu chain of supermarkets and pharmacies.

MONROVIA, Calif. — Stayhealthy on Wednesday announced the completion of its deployment of Stayhealthy HealthCENTER Kiosks in six states throughout the Supervalu chain of supermarkets and pharmacies. Supervalu, which operates Cub, Farm Fresh, Shoppers and Shop ‘n Save, is now home to Stayhealthy’s FDA-cleared, self-monitoring HealthCENTERs that provide clinical-grade health screenings free of charge, the company stated. 

March 18, 2014

The Consumer Healthcare Products Association this year will be focusing on restoring OTC eligibility under flexible spending accounts and helping to finalize OTC monographs, Scott Melville, CHPA president and CEO, told attendees of the 2014 CHPA Annual Executive Conference Tuesday morning.

AMELIA ISLAND, Fla. — The Consumer Healthcare Products Association this year will be focusing on restoring OTC eligibility under flexible spending accounts and helping to finalize OTC monographs, Scott Melville, CHPA president and CEO, told attendees of the 2014 CHPA Annual Executive Conference Tuesday morning. 

March 10, 2014

A Maryland bill that is intended to help pharmacies in managing inventories and avoid potential drug shortages could create hardships for distributors, according to an FDA law blog.

WASHINGTON — A Maryland bill that is intended to help pharmacies in managing inventories and avoid potential drug shortages could create hardships for distributors, according to an FDA law blog.

March 6, 2014

In anticipation of the March 13 deadline for comments on the FDA's proposed rule on prescription generic drug labeling, 21 health industry groups submitted a new letter to the agency on Thursday, raising concerns about the proposed regulation.

WASHINGTON — In anticipation of the March 13 deadline for comments on the FDA's proposed rule on prescription generic drug labeling, 21 health industry groups submitted a new letter to the agency on Thursday, raising concerns about the proposed regulation. 

February 27, 2014

LED Technologies announced has formed an alliance with Kathy Ireland Worldwide to develop reVive Light Therapy skin care devices for anti-aging; uneven skin tone and hyperpigmantation; acne; and skin healing.

DENVER — LED Technologies announced has formed an alliance with Kathy Ireland Worldwide to develop reVive Light Therapy skin care devices for anti-aging; uneven skin tone and hyperpigmantation; acne; and skin healing.

The FDA-approved reVive Light Therapy features a collection that offers full face as well as hand-held light devices, across a full range LED Light Modalities.

February 20, 2014

Kremers Urban Pharmaceuticals announced the launch of rabeprazole sodium delayed-release tablets, which are used to treat gastroesophageal reflux disease in adults and adolescents.

PRINCETON, N.J. — Kremers Urban Pharmaceuticals, a subsidiary of UCB, announced the launch of rabeprazole sodium delayed-release tablets. The drug is used to treat gastroesophageal reflux disease in adults and adolescents, according to the FDA.

The product is the bioequivalent to Aciphex from Eisai. Kremers Urban rabeprazole sodium delayed-release tablets are available in 20-mg strength in both 30- and 90-count bottles.

February 14, 2014

Global public health organization NSF International has launched the NSF Cosmetics and Personal Care Program to provide auditing, training, product testing, claim substantiation and certification services to enable manufacturers to improve the quality and safety of their products, and retailers to strengthen the oversight of their cosmetic and personal care suppliers, the organization announced on Friday.

ANN ARBOR, Mich. — Global public health organization NSF International has launched the NSF Cosmetics and Personal Care Program to provide auditing, training, product testing, claim substantiation and certification services to enable manufacturers to improve the quality and safety of their products, and retailers to strengthen the oversight of their cosmetic and personal care suppliers, the organization announced on Friday.

February 11, 2014

Joining the ranks of Hy-Vee and Meijer, HomeTown Pharmacy, which is based here in Newaygo, has announced that it is now offering free flu and strep throat testing as part of a collaborative patient care study.

NEWAYGO, Mich. — Joining the ranks of Hy-Vee and Meijer, HomeTown Pharmacy, which is based here in Newaygo, has announced that it is now offering free flu and strep throat testing as part of a collaborative patient care study.

February 3, 2014

The Generic Pharmaceutical Association on Monday identified its key priorities for 2014 — guarding against confusion a proposed labeling change would cause; gaining access to biosimilar generics; and heralding the cost savings generated by generic utilization.

WASHINGTON — The Generic Pharmaceutical Association on Monday identified its key priorities for 2014 — guarding against confusion a proposed labeling change would cause; gaining access to biosimilar generics; and heralding the cost savings generated by generic utilization. 

January 30, 2014

Novartis Consumer Health will be relaunching Theraflu for the 2014-2015 cough-cold season, Brian McNamara, Novartis division head OTC, told analysts.

BASEL, Switzerland — Novartis Consumer Health will be relaunching Theraflu for the 2014-2015 cough-cold season, Brian McNamara, Novartis division head OTC, told analysts Wednesday. 

"As you know, in the U.S. business we launched Lamisil and Triaminic and Excedrin end of 2012 and 2013. About halfway through the year, we launched Benefiber. And for next year, we expect to launch Theraflu for that cough and cold season," he said. 

January 27, 2014

Walgreens Infusion Services on Monday announced that it has been selected as the preferred provider of home administration services for Makena (hydroxyprogesterone caproate injection), the only FDA-approved medication to help reduce the risk of preterm birth for clinically indicated patients.

DEERFIELD, Ill. — Walgreens Infusion Services on Monday announced that it has been selected as the preferred provider of home administration services for Makena (hydroxyprogesterone caproate injection), the only FDA-approved medication to help reduce the risk of preterm birth for clinically indicated patients. Makena is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

December 26, 2013

The Food and Drug Administration declined to approve an experimental contraceptive patch developed by Actavis, the drug maker said Tuesday.

DUBLIN — The Food and Drug Administration declined to approve an experimental contraceptive patch developed by Actavis, the drug maker said Tuesday.

Actavis said the FDA sent it a complete response letter for its progestin-only transdermal contraceptive patch. A complete response letter means that the agency has finished reviewing a drug-approval application, but questions remain that preclude final approval.

November 18, 2013

A bill that would implement federal tracking and tracing of drugs and strengthen federal regulations on pharmacy compounding has passed in the Senate and will go to President Barack Obama for his signature.

NEW YORK — A bill that would implement federal tracking and tracing of drugs and strengthen federal regulations on pharmacy compounding has passed in the Senate and will go to President Barack Obama for his signature.

November 13, 2013

A new study conducted by researchers at CVS Caremark and Brigham and Women's Hospital explored the impact of genetic testing on prescribing patterns for cardiovascular therapy.

WOONSOCKET, R.I. — A new study conducted by researchers at CVS Caremark and Brigham and Women's Hospital explored the impact of genetic testing on prescribing patterns for cardiovascular therapy and found that there is an opportunity to improve upon the information physicians and patients receive on the evolving body of evidence for pharmacogenomics.

October 30, 2013

Tria Beauty, a maker of light-based skin care, has received FDA clearance for the company's Age-Defying Laser, the company has announced.

DUBLIN, Calif. — Tria Beauty, a maker of light-based skin care, has received clearance from the Food and Drug Administration for the company's Age-Defying Laser, the company has announced.

October 25, 2013

Guiding Stars really works. That’s the finding of an independent study that examined the Guiding Stars nutrition guidance program at more than 100 Hannaford grocery stores.

PORTLAND, Maine — Guiding Stars really works. That’s the finding of an independent study that examined the Guiding Stars nutrition guidance program at more than 100 Hannaford grocery stores.

According to the study, which focused on ready-to-eat cereals, the program influences grocery shoppers' selections and significantly increases demand for products that are rated more nutritious, at the expense of those that are not. The findings were published in the journal Food Policy.

September 20, 2013

Perrigo Co. has hired a former Food and Drug Administration official for its regulatory department, the drug maker said.

ALLEGAN, Mich. — Perrigo Co. has hired a former Food and Drug Administration official for its regulatory department, the drug maker said Friday.

The Allegan, Mich.-based drug maker announced the appointment of Keith Webber as head of regulatory review, a position in which he will start on Oct. 21. Webber previously served as acting director of the FDA's Office of Pharmaceutical Science, part of the Center for Drug Evaluation and Research, which regulates prescription and OTC drugs. He also served as director of the Office of Generic Drugs.

September 16, 2013

The Food and Drug Administration is barring the importation of drugs from another one of Ranbaxy Labs' plants in India, the agency said Monday.

SILVER SPRING, Md. – The Food and Drug Administration is barring the importation of drugs from another one of Ranbaxy Labs' plants in India, the agency said Monday.

September 12, 2013

Contigo, an Ignite USA LLC brand, announced a new reusable tumbler with a lid that snaps shut to ensure 100% leak-proof shaking and mixing to prepare on-the-go drinks and shakes.

CHICAGO — Contigo, an Ignite USA LLC brand, announced on Thursday a new reusable tumbler with a lid that snaps shut to ensure 100% leak-proof shaking and mixing to prepare on-the-go drinks and shakes.

September 10, 2013

It also is important to note the success of Colgate's Optic White toothpaste.

NEW YORK — It also is important to note the success of Colgate's Optic White toothpaste. According to IRI, it raked in $141.1 million in year-one dollar sales and took the No. 2 spot in IRI's 2012 New Product Pacesetters: Top 10 Non-Food Brands report released earlier this year.