SPECIALTY RX FACTS

18Sep/120

FDA Approves new MS drug.

CAMBRIDGE, Mass. — The Food and Drug Administration has approved a new drug for multiple sclerosis.

Sanofi subsidiary Genzyme announced that the FDA had approved Aubagio (teriflunomide) as a once-daily, oral treatment for patients with relapsing MS.

"We are very excited to introduced Aubagio as a new treatment option that can make a difference in the lives of people with multiple sclerosis," Genzyme president and CEO David Meeker said. "The approval of our first MS therapy represents an important milestone for Genzyme and underscores our commitment to long-term leadership and partnership in the MS community."

 

Filed under: FDA No Comments
30Aug/120

Great Future Opportunity for Specialty Pharmacy: Teva gets approval on copy of Neupogen

U.S. drug regulators gave the nod to a Teva Pharmaceutical Industries drug that boosts the production of infection-fighting white blood cells in certain cancer patients receiving chemotherapy. Teva's medicine is in many ways a copy of Amgen Inc's biologic drug Neupogen, which faces the expiration of its U.S. patent next year. In an a settlement of patent litigation, Teva agreed last year to refrain from launching its versions of Neupogen and Neulasta, Amgen's longer-lasting white blood cell booster, in the United States until November 2013.

Filed under: FDA No Comments
17Jul/120

FDA Announces New Director of the Office of Generic Drugs

The Office of Pharmaceutical Science (OPS) is pleased to announce the selection of Gregory P. Geba, M.D., M.P.H., as Director of the Office of Generic Drugs (OGD) effective July 15, 2012.

Dr. Geba has served in senior-level clinical/managerial positions in the pharmaceutical industry for the past 15 years. He most recently served as Deputy Chief Medical Officer for Sanofi US, where he provided medical and scientific leadership and managerial direction to a staff of approximately 500 multidisciplinary scientific and regulatory professionals engaged in drug development activities across all therapeutic areas, as well as to the company’s field medical group.

He has contributed to the registration of more than 20 currently marketed drugs or devices across multiple therapeutic areas. In so doing, he successfully employed his working knowledge and demonstrated practical application of drug manufacturing processes, current quality and risk management processes, and standards relevant to FDA’s laws and regulations. He brings extensive clinical research experience, including leading or serving as the key point in filing new drug applications, biologic license applications, and promotional studies comparing efficacy and effectiveness of novel biopharmaceuticals versus standard of care (including regimens containing branded or generic drugs), and has provided or supervised key safety updates and presentations to FDA Advisory Committees. Dr. Geba’s experience also includes leading medical affairs activities while serving in a variety of senior-level positions. His scope of responsibility in those activities included contribution to the design of experimental protocols and assessment of data from pre-clinical, animal, and first-in-human studies; design, implementation, analysis, and interpretation of phase 2a proof-of-concept and 2b dose ranging studies; and production of important comparative effectiveness and safety data when assessing benefit-risk relationships during phase 3, phase 3b, and phase 4 studies.

Dr. Geba received his medical degree from the University of Navarre and his M.P.H. from the Johns Hopkins Bloomberg School of Public Health. He joins OGD at an opportune time to lead our expanding generic program into a reorganization of both structure and process to improve coordination, communication, and efficiency, as well as enhance the Office’s ability to ensure that all generic drugs—which make up nearly 80 percent of prescriptions filled in the United States—are safe, effective, of high quality, and interchangeable with the brand name drug product/reference listed drug.

 

Filed under: FDA No Comments
9Jul/120

Unapproved Oxycodone Drugs Ordered Off the Market by FDA

Unapproved manufacturers of the painkiller oxycodone are being targeted by the FDA and being asked to halt production and distribution. The Unapproved Drugs initiative, started in 2006, is intended to remove drugs from the market that have not gone through the appropriate measures of approval. “Federal Register” notices have been given to manufacturers of multiple unapproved drugs, some of which date back to the 1800’s. The current notice is aimed at single ingredient, instant-release drugs that contain oxycodone. Oxycodone, known on the streets as “Oxy”, has been labeled a controlled substance by the government because of the high rates of overdose and abuse.

"It's a high public health priority for FDA to remove these unapproved products from the market to minimize consumer exposure to drugs that may be unsafe, ineffective and of poor quality," FDA Center for Drug Evaluation and Research Office of Compliance acting director Lisa Bernstein said. "Since FDA-approved versions of these oral dosage forms are available by prescription, there should be no negative impact on consumers as a result of this action and no disruptions to the drug supply."

 

Filed under: FDA No Comments
18Jan/120

FDA Submits Generic, Brand Drug User Fee Bill Language to Congress

FDA Submits Generic, Brand Drug User Fee Bill Language to Congress

Generic drugmakers won’t have long to wait after Congress passes a user fee bill to learn the various fee levels in the Generic Drug User Fee Act (GDUFA).  Under statutory language delivered to Capitol Hill on Friday, the FDA would
have only until Oct. 31 to establish fee levels for a one-time backlog fee, a drug master file fee and various application and supplement fees.

Filed under: FDA No Comments
3Aug/110

FDA Posts New Draft Document on 501 (k) Premarket Notifications

FDA developed a draft document to provide guidance to manufacturers on when to submit a premarket notification submission (510(k)) for changes or modifications made to that manufacturer’s1 previously cleared medical device. The underlying principles that FDA uses to determine when a 510(k) is necessary for a modified device are explained, and examples are provided for additional clarity. When final, this guidance will supersede the 1997 version of the guidance document..

While the suggestions are modest in nature we suggest you review this document for importance to your organization.  D2 has a broad network of specialists focus on the commercialization of devices.

For a full review of the draft document please click on http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm265274.htm#1

 

Filed under: FDA No Comments
27Apr/110

FDA Approves Rituxan to Treat Two Rare Disorders

 SILVER SPRING, Md., April 19, 2011

 The U.S. Food and Drug Administration today approved Rituxan (rituximab), in combination with glucocorticoids (steroids), to treat patients with Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA), two rare disorders that cause blood vessel inflammation (vasculitis).

Vasculitis in patients with WG and MPA can lead to tissue damage. WG mostly affects the respiratory tract (sinuses, nose, trachea, and lungs) and kidneys, while MPA commonly affects the kidneys, lungs, nerves, skin, and joints. Both of these diseases affect people of all ages and ethnicities, and both genders. The causes of these disorders are unknown, and both are considered orphan diseases because they each affect less than 200,000 people in the United States.

"This new indication for Rituxan provides the first approved therapy for these two orphan diseases," said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research.

Rituxan is an antibody that is manufactured through biotechnology methods. The drug works by greatly reducing the number of specific immune cells in the blood, known as B cells.  

The safety and effectiveness of Rituxan was demonstrated in a single controlled trial, in which 197 patients with WG or MPA were assigned at random to receive either Rituxan plus glucocorticoids once a week for four weeks or oral cyclophosphamide plus glucocorticoids daily to induce remission. After six months, 64 percent of patients treated with Rituxan had complete remission compared to 53 percent of patients treated with cyclophosphamide.  

Retreatment with Rituxan was not formally evaluated; therefore, the safety and efficacy of retreatment with subsequent courses of Rituxan has not been established. More data are needed to determine the safety of more than one course of Rituxan and long term safety of use of Rituxan in patients with WG and MPA. These questions will be further evaluated in a required post-marketing study.

Rituxan carries a Boxed Warning for infusion reactions, which can occur during infusion or within 24 hours afterwards. Other Boxed Warnings for Rituxan include rashes and sores in the skin and mouth (severe mucocutaneous reactions); and progressive multifocal leukoencephalopathy, a brain infection that generally is fatal. Rituxan is not recommended for use in patients with severe, active infections.

The most common side effects in study participants with WG and MPA included infection, nausea, diarrhea, headache, muscle spasms, and anemia.

Rituxan, which has been marketed since 1997, is also indicated for the treatment of patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

Rituxan is manufactured by San Francisco-based Genentech, a member of the Roche Group.

Filed under: FDA No Comments
20Apr/110

FDA Approves Genentech (RHHBY)’s Rituxan to Treat Two Rare Disorders

SILVER SPRING, Md., April 19, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Rituxan (rituximab), in combination with glucocorticoids (steroids), to treat patients with Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA), two rare disorders that cause blood vessel inflammation (vasculitis).

Vasculitis in patients with WG and MPA can lead to tissue damage. WG mostly affects the respiratory tract (sinuses, nose, trachea, and lungs) and kidneys, while MPA commonly affects the kidneys, lungs, nerves, skin, and joints. Both of these diseases affect people of all ages and ethnicities, and both genders. The causes of these disorders are unknown, and both are considered orphan diseases because they each affect less than 200,000 people in the United States.

"This new indication for Rituxan provides the first approved therapy for these two orphan diseases," said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research.

Rituxan is an antibody that is manufactured through biotechnology methods. The drug works by greatly reducing the number of specific immune cells in the blood, known as B cells.

The safety and effectiveness of Rituxan was demonstrated in a single controlled trial, in which 197 patients with WG or MPA were assigned at random to receive either Rituxan plus glucocorticoids once a week for four weeks or oral cyclophosphamide plus glucocorticoids daily to induce remission. After six months, 64 percent of patients treated with Rituxan had complete remission compared to 53 percent of patients treated with cyclophosphamide.

Retreatment with Rituxan was not formally evaluated; therefore, the safety and efficacy of retreatment with subsequent courses of Rituxan has not been established. More data are needed to determine the safety of more than one course of Rituxan and long term safety of use of Rituxan in patients with WG and MPA. These questions will be further evaluated in a required post-marketing study.

Rituxan carries a Boxed Warning for infusion reactions, which can occur during infusion or within 24 hours afterwards. Other Boxed Warnings for Rituxan include rashes and sores in the skin and mouth (severe mucocutaneous reactions); and progressive multifocal leukoencephalopathy, a brain infection that generally is fatal. Rituxan is not recommended for use in patients with severe, active infections.

The most common side effects in study participants with WG and MPA included infection, nausea, diarrhea, headache, muscle spasms, and anemia.

Rituxan, which has been marketed since 1997, is also indicated for the treatment of patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

Rituxan is manufactured by San Francisco-based Genentech, a member of the Roche Group.

For more information:

Approved Drugs: Questions and Answers
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

Filed under: FDA No Comments
15Apr/110

FDA Pushes Global Strategy to Better Secure Supply Chain

 The FDA’s work toward tighter supply chain control through international regulatory cooperation is falling short, but a new global strategy may speed up the agency’s progress, a top FDA official says. The next several years are critical in the agency’s transformation to a “global agency,” John Taylor, the FDA’s acting principal deputy commissioner, said Feb. 14 at a Pew Charitable Trusts conference in Washington, D.C., on supply chain safety. To achieve adequate supply chain control, Taylor said, the FDA needs novel and updated enforcement tools, a global alliance of regulators, new authorities to create proactive tools for product safety, adequate funding for inspections, examinations and sample collections and analysis, and updated systems, including IT support, to assist with increased workload.

Filed under: FDA No Comments
11Apr/110

FDA Approval Makes AstraZeneca’s Vendetanib First Thyroid Concer Drug

AstraZeneca has received FDA approval for vandetanib as an orphan drug treatment for medullary thyroid cancer that cannot be removed by surgery or has spread to other parts of the body. While AstraZeneca has not disclosed a launch date, “we will work to make [vandetanib] available to patients as soon as possible and will make another announcement at that time,” AstraZeneca spokeswoman Laura Woodin told DID. Apparently, the FDA nixed the trade name Zictifa, the second name AstraZeneca has attached to the drug. It is “working with the FDA on a new trade name,” Woodin said.

Filed under: FDA No Comments