Content about Food and Drug Administration

February 25, 2014

The Food and Drug Administration has approved Myalept (metreleptin for injection) to treat complications of leptin deficiency in patients with congenital generalized or acquired generalized lipodystrophy, a condition associated with a lack of fat tissue.

SILVER SPRING, Md. — The Food and Drug Administration has approved Myalept (metreleptin for injection) to treat complications of leptin deficiency in patients with congenital generalized or acquired generalized lipodystrophy, which is a condition associated with a lack of fat tissue.

February 21, 2014

Food and Drug Administration Office of Generic Drugs' acting director Kathleen Uhl highlighted the industry and FDA’s shared commitment to Generic Drug User Fee Act milestones and approaching metrics in her keynote address at the GPhA Annual Meeting taking place here.

ORLANDO, Fla. — Food and Drug Administration Office of Generic Drugs' acting director Kathleen Uhl on Thursday highlighted the industry and FDA’s shared commitment to Generic Drug User Fee Act milestones and approaching metrics in her keynote address at the GPhA Annual Meeting taking place here.

February 21, 2014

The Food and Drug Administration will host a public meeting in March to discuss updating the OTC monograph system, the Wall Street Journal reported Friday.

SILVER SPRING, Md. — The Food and Drug Administration will host a public meeting in March to discuss updating the OTC monograph system, the Wall Street Journal reported Friday

According to the report, the FDA will consider improving the agency's ability to initiate label changes quickly, allowing for faster innovation from manufacturers and imposing new pediatric dosing limits based on the most recent science. 

February 20, 2014

The Food and Drug Administration recently approved two "robotic pills," or pills that place an image camera or ingestible sensors into the gastrointestinal tract, according to a report published earlier this week by the Wall Street Journal.

NEW YORK — The Food and Drug Administration recently approved two "robotic pills," or pills that place an image camera or ingestible sensors into the gastrointestinal tract, according to a report published earlier this week by the Wall Street Journal

Other robotic pills still in development include one backed by Google — a pill that would replace injectable drugs, the report noted. 

February 19, 2014

The Food and Drug Administration announced that it has approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension.

SILVER SPRING, Md. — The Food and Drug Administration announced that it has approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension.

NOH is a rare, chronic drop in blood pressure upon standing that's associated with Parkinson's disease, multiple-system atrophy and pure autonomic failure. Symptoms include dizziness, lightheadedness, blurred vision, fatigue and fainting when a person stands.

February 19, 2014

The Food and Drug Administration announced the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. 

In August 2013, the FDA published a notice in the Federal Register (78 FR 51192) to solicit companies to voluntarily submit applications for participation in this two-year program. Thirteen prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected drug products into the United States.

February 18, 2014

This year, ECRM celebrates 20 years of successfully pairing buyers and sellers across the consumer packaged goods industry.

This year, ECRM celebrates 20 years of successfully pairing buyers and sellers across the consumer packaged goods industry. As part of that celebration, and in correlation to the ECRM Cough-Cold, Analgesics and Allergy event, DSN editors thought it’d be a good idea to look back through the last 20 years of the cough-cold business at retail.

February 18, 2014

In a blog post updated Friday, Food and Drug Administration commissioner Margaret Hamburg addressed two challenges facing Indian drug manufacturers — approval times for abbreviated new drug applications and quality inspections.

SILVER SPRING, Md. — In a blog post updated Friday, Food and Drug Administration commissioner Margaret Hamburg addressed two challenges facing Indian drug manufacturers — approval times for abbreviated new drug applications and quality inspections. 

February 18, 2014

To put it in Facebook terms, the pharmaceutical industry by and large has yet to friend American consumers.

To put it in Facebook terms, the pharmaceutical industry by and large has yet to friend American consumers.

A new report from the IMS Institute for Healthcare Informatics concludes that fewer than half of the top 50 global pharmaceutical manufacturers “have some level of healthcare social media engagement.” This, despite the fact that “increasingly, patients are turning to social media as an essential forum for obtaining and sharing information related to their health,” noted Murray Aitken, the institute’s executive director.

February 18, 2014

Sun Pharmaceutical Industries announced that the Food and Drug Administration has granted final approval for its generic version of Temodar temozolomide capsules in 5-mg, 20-mg, 100-mg 140-mg, 180-mg and 250-mg form.

MUMBAI — Sun Pharmaceutical Industries announced that the Food and Drug Administration has granted final approval for its generic version of Temodar temozolomide capsules in 5-mg, 20-mg, 100-mg 140-mg, 180-mg and 250-mg form.

February 18, 2014

The Food and Drug Administration has approved Vimizim (elosulfase alfa), the first FDA-approved treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome), which is a rare disease caused by a deficiency in N-acetylgalactosamine-6-sulfate sulfatase (GALNS).

SILVER SPRING, Md. — The Food and Drug Administration has approved Vimizim (elosulfase alfa), the first FDA-approved treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome), which is a rare disease caused by a deficiency in N-acetylgalactosamine-6-sulfate sulfatase (GALNS).

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 13, 2014

After meeting for two days earlier this week, the Food and Drug Administration's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 16-9 against changing the label of naproxen to highlight a lower cardiovascular risk profile as compared to other NSAIDs, according to published reports.

SILVER SPRING, Md. — After meeting for two days earlier this week, the Food and Drug Administration's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 16-9 against changing the label of naproxen to highlight a lower cardiovascular risk profile as compared to other NSAIDs, according to published reports. 

Those advisory panels who voted against the change felt the data were insufficient to say naproxen was safer than other NSAIDs.

February 13, 2014

Janssen Biotech announced that the Food and Drug Administration has approved Imbruvica (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior therapy.

HORSHAM, Pa. — Janssen Biotech on Wednesday announced the Food and Drug Administration has approved Imbruvica (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior therapy. Imbruvica was first approved in November 2013 for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Both indications are based on an overall response rate. An improvement in survival or disease-related symptoms has not been established.

February 13, 2014

Teva Pharmaceutical Industries announced that the Food and Drug Administration has granted full approval of Synribo (omacetaxine mepesuccinate) for injection.

JERUSALEM — Teva Pharmaceutical Industries on Thursday announced that the Food and Drug Administration has granted full approval of Synribo (omacetaxine mepesuccinate) for injection.

The drug is indicated for adult patients with chronic phase or accelerated phase chronic myeloid leukemia with resistance and/or intolerance to two or more tyrosine kinase inhibitors.

February 12, 2014

America’s biopharmaceutical research companies currently are developing 180 new medicines to help the nearly 400 million people who have diabetes worldwide, the Pharmaceutical Research and Manufacturers of America announced Tuesday.

WASHINGTON — America’s biopharmaceutical research companies currently are developing 180 new medicines to help the nearly 400 million people who have diabetes worldwide, the Pharmaceutical Research and Manufacturers of America announced Tuesday. These medicines in development — all either in clinical trials or under review by the Food and Drug Administration — include 30 for type 1 diabetes, 100 for type 2 and 52 for diabetes-related conditions.

February 11, 2014

The Generic Pharmaceutical Association announced its support of Georgia SB 370, introduced by pharmacist and Sen. Buddy Carter, R-Ga. District 1, because it will allow unimpeded patient access to interchangeable biologics.

WASHINGTON — The Generic Pharmaceutical Association on Tuesday announced its support of Georgia SB 370, introduced by pharmacist and Sen. Buddy Carter, R-Ga. District 1,  because it will allow unimpeded patient access to interchangeable biologics. The bill mirrors current pharmacy practice for interchangeable generic substitution language, and is aligned with Food and Drug Administration definitions, the association noted.

February 11, 2014

Multicultural cosmetics brand Milani has hit the ground running this year with a new leadership team, a re-energized brand platform and marketing and communications plans to enter its next evolution in business in 2014.

LOS ANGELES — Multicultural cosmetics brand Milani has hit the ground running this year with a new leadership team, a re-energized brand platform and marketing and communications plans to enter its next evolution in business in 2014.

As the brand embarks on its next stage of evolution, a new team of executives has taken on leadership roles at Milani:

February 10, 2014

AliveCor announced that the Food and Drug Administration has granted the company over-the-counter clearance for the AliveCor Heart Monitor, a single-channel ECG (electrocardiogram) recorder, previously available by prescription only.

SAN FRANCISCO — AliveCor on Monday announced that the Food and Drug Administration has granted the company over-the-counter clearance for the AliveCor Heart Monitor, a single-channel ECG (electrocardiogram) recorder, previously available by prescription only. The device is available now for pre-order purchase with shipments beginning in March.

February 7, 2014

A new and possibly transformative technology for rapidly diagnosing and evaluating patients based on their specific genetic profile may soon begin appearing at retail pharmacies and clinics, giving pharmacists and clinicians another tool for advancing patient health outcomes and their own practice capabilities.

A new and possibly transformative technology for rapidly diagnosing and evaluating patients based on their specific genetic profile may soon begin appearing at retail pharmacies and clinics, giving pharmacists and clinicians another tool for advancing patient health outcomes and their own practice capabilities.

Dr. Anita Goel, M.D., Ph.D.

February 6, 2014

The Food and Drug Administration published an interim final rule to further safeguard the health of infants fed infant formula in the United States.

SILVER SPRING, Md. — The Food and Drug Administration on Thursday published an interim final rule to further safeguard the health of infants fed infant formula in the United States. The rule, which sets standards for manufacturers to produce safe infant formula that supports healthy growth, is accompanied by two draft guidance documents for industry.

February 6, 2014

The Food and Drug Administration’s proposed rule on prescription drug labeling would add $4 billion annually to the nation’s healthcare costs, undercutting the cost savings that generic medicines have brought to America’s patients and healthcare system, according to an analysis released Wednesday by economic consulting firm Matrix Global Advisors.

WASHINGTON — The Food and Drug Administration’s proposed rule on prescription drug labeling would add $4 billion annually to the nation’s healthcare costs, undercutting the cost savings that generic medicines have brought to America’s patients and healthcare system, according to an analysis released Wednesday by economic consulting firm Matrix Global Advisors.

February 4, 2014

The Food and Drug Administration on Tuesday unveiled its first youth tobacco prevention program, “The Real Cost,” which will target at-risk youth ages 12 to 17 who are open to smoking or already experimenting with cigarettes.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday unveiled its first youth tobacco prevention program, “The Real Cost,” which will target at-risk youth ages 12 to 17 years who are open to smoking or already experimenting with cigarettes. About 10 million youth in the United States currently fall into this category.

The campaign launches nationally Feb. 11. 

February 4, 2014

Salix Pharmaceuticals announced that the Food and Drug Administration has accepted for filing a new drug application for Budesonide 2 mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

RALEIGH, N.C. — Salix Pharmaceuticals last week announced that the Food and Drug Administration has accepted for filing a new drug application for Budesonide 2 mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

The FDA has issued an action date of Sept. 15, 2014 under the Prescription Drug User Fee Act. 

February 3, 2014

The Food and Drug Administration is investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products, the agency announced Friday.

SILVER SPRING, Md. — The Food and Drug Administration is investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products, the agency announced Friday.