Archive for the 'From FDA' Category
June 12th, 2010 by admin
In a major setback to pharma major Dr. Reddy’s Laboratories, a court in the U.S. has passed an injunction order against the company, refraining it from launching its generic version of Allegra D24 in the U.S. market.
Dr. Reddy’s which had received approval from the US FDA to market the drug in March has said that it disagreed with the court’s decision and would file an appeal.
According to estimates, the market size for this drug is around $200 million.
The District Court of New Jersey granted a preliminary injunction on the launch of Allegra D 24 based on an application filed by Albany Molecular Research Inc (AMRI) and Sanofi-Aventis.
In September 2009, AMRI filed a patent infringement lawsuit in the court against Dr. Reddy’s Lab for infringement of one of its patents related to the manufacturing process for the active ingredient in Allegra, Allegra-D 12, and Allegra-D 24 hour and joined hands with French drug maker Sanofi-Aventis SA, which sells Allegra to file the law suit.
Dr. Reddy’s had agreed to hold the launch of Allegra-D in the U.S. markets until the hearing in May. Now the company would need to wait further till its appeal is taken up for hearing.
Source: The Hindu; June 12, 2010
April 3rd, 2010 by admin
The US Food and Drug Administration (FDA) today notified healthcare professionals that the agency is evaluating data from a clinical trial indicating that patients with Parkinson’s disease (PD) receiving treatment with a combination of entacapone, carbidopa, and levodopa (Stalevo, Novartis) may be at increased risk for prostate cancer.
The trial, called Stavelo Reduction in Dyskinesia Evaluation – Parkinson’s Disease (STRIDE-PD), is a randomized comparison of entacapone/carbidopa/levodopa vs carbidopa/levodopa (Sinemet) in patients with PD.
“At this time, FDA’s review of Stalevo is ongoing and no new conclusions or recommendations about the use of this drug have been made,” the MedWatch alert cautions. Healthcare professionals should be aware of this possible risk, they add, and follow current guidelines for prostate cancer screening.
STRIDE-PD
The STRIDE-PD trial was a double-blind, randomized, parallel group, controlled clinical trial conducted at 77 centers in 14 countries, including the United States, the release notes. The primary endpoint was time to onset of dyskinesia in PD patients between treatment groups. A total of 745 PD patients were enrolled, and 541 completed treatment, 265 receiving entacapone/levodopa/carbidopa and 276 receiving carbidopa/levodopa only.
Mean treatment duration was 2.7 years, ranging up to 4 years. The average age of patients was approximately 60 years, the age at which prostate cancer is most commonly diagnosed, the alert points out; most were white (95.2%) and male (62.7%).
“An unexpected finding in the trial was that a greater number of patients taking Stalevo were observed to have prostate cancer compared to those taking carbidopa/levodopa,” the alert notes.
Specifically, 9 of 245 men (3.7%; 95% confidence interval [CI], 1.69% – 6.86%) had prostate cancer in the entacapone/levodopa/carbidopa group vs 2 of 222 men (0.9%) in the carbidopa/levodopa group, for an incidence rate of 14 cases per 1,000 with entacapone/levodopa/carbidopa compared with 3.2 cases per 1,000 with carbidopa/levodopa.
The odds ratio for the occurrence of prostate cancer in men taking entacapone/levodopa/carbidopa was 4.19 (95% CI, 0.90 – 19.63) vs carbidopa/levodopa.
Duration of entacapone/levodopa/carbidopa therapy before a diagnosis of prostate cancer ranged from 148 to 949 days, with a mean of 664 days. Previous trials of this entacapone/levodopa/carbidopa therapy did not indicate any such increased risk for prostate cancer, but most of these trials were conducted for less than a year, the alert points out.
The additional drug in this combination, entacapone, is also sold as a single-ingredient product (Comtan), also used to treat PD symptoms, and likewise has not been previously associated with an increased risk for prostate cancer.
“The agency is exploring additional ways to better understand if Stalevo actually increases the risk of prostate cancer,” they write. “This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety review of drugs. The agency will update the public as soon as this review is complete.”
Source: Fierce Pharma April 1, 2010 — 9:51am ET
February 15th, 2010 by admin
Abbott announced that the U.S. Food and Drug Administration (FDA) has granted approval of a new tablet formulation of the company’s antiretroviral medication Norvir® (ritonavir). The new Norvir tablets can be stored at room temperature and do not require refrigeration, making it more convenient for patients. The Norvir tablets and the Norvir soft-gelatin capsules both contain 100 mg of ritonavir. While the rate of drug absorbed is different, there is no requirement for dosage change. Norvir is used in combination with other antiretroviral medications to treat HIV. All forms of Norvir, including the soft-gel capsule and liquid form, remain available in the United States.
“Norvir has been a critical component of HIV treatment for many patients. The innovation behind the development of the Norvir tablet is the direct result of years of effort by Abbott scientists to address the needs of people living with HIV,” said Scott Brun, M.D., divisional vice president, infectious disease development, Global Pharmaceutical Research and Development, Abbott. “Abbott has been dedicated to finding new and more convenient ways for patients to manage their HIV through the development of novel diagnostics testing methods and medications for more than 20 years.”
Abbott scientists evaluated several candidate formulations before developing the final Norvir tablet formulation. The Norvir tablet was developed using Abbott’s Meltrex® technology, a proprietary melt-extrusion process, making it more heat-stable. This is the same technology used to develop Abbott’s Kaletra® (lopinavir/ritonavir) tablet, which combines lopinavir and ritonavir.
“Approximately one-third of all HIV-positive patients in treatment use Norvir in combination with other antiretroviral medicines. The heat-stable tablet formulation may allow these patients greater flexibility to store and carry their medication with them,” said Renslow Sherer, M.D., professor of medicine, section of infectious diseases and global health and director, International HIV Training Center, University of Chicago Hospitals. “For patients who may not have access to refrigeration, this new formulation is also important.”
For more than 20 years, Abbott has made a significant contribution to the fight against HIV/AIDS through the development of innovative tests and medicines.
- In 1985, Abbott developed the first licensed test to detect HIV antibodies in the blood. The company remains a leader in HIV diagnostics today
- In 1992, Abbott was the first company to receive FDA approval for an HIV diagnostic assay. Abbott retroviral and hepatitis tests are used to screen more than half of the world’s donated blood supply
- In 1996, Norvir was approved for the treatment of HIV in the United States. Norvir was one of the first protease inhibitors on the market and remains one of the most commonly prescribed medicines as part of combination therapy
- In 1997, Norvir became one of the first protease inhibitors to receive FDA clearance for use in children
- In 2000, Abbott received FDA accelerated approval for Kaletra
- In 2005, the tablet form of Kaletra received FDA approval
- In 2006, Kaletra tablets received EMEA approval
- In 2007, Abbott received FDA approval for a new lower-strength Kaletra tablet suitable for pediatric use
- In 2007, Abbott’s RealTime HIV-1 Viral Load test was approved by the FDA for use on the m2000™ molecular diagnostics instruments
- In 2009, Abbott received approval from the FDA for its ABBOTT PRISM HIV O Plus test, the first fully-automated blood screening test for HIV-1/HIV-2
- In 2010, the FDA approved the new Norvir tablet
More information may also be found on Abbott.com/HIV.
Source
December 16th, 2009 by admin
NEWS – Monday, December 14, 2009
Federal scientists say AstraZeneca’s cholesterol pill Crestor lowers the risk of heart attack, death and stroke in patients without a history of heart disease, though some safety concerns remain.
In documents posted online Friday, the Food and Drug Administration cites the findings of AstraZeneca’s study released last November. The study showed that patients with lower cholesterol and few heart risks could still benefit from taking Crestor, setting the stage for a dramatic expansion in use of the drug that already exceeds US$1 billion in annual sales.
The British drugmaker wants the FDA to broaden Crestor’s labeling based on those results.
But the FDA’s review also cites several safety concerns, including a higher rate of diabetes in patients taking Crestor.
About 2.8 percent of patients taking Crestor in the 17,000-patient Jupiter study developed diabetes, compared with 2.3 percent of patients taking a dummy pill. The difference was statistically significant, according to the FDA.
But one FDA reviewer suggests that diabetes is a side effect of all drugs in that class, which include Crestor, Pfizer’s Lipitor and other cholesterol-lowering pills.
“It is this clinical reviewer’s opinion that the treatment benefit observed in the Jupiter trial outweighs the risk, but further clinical trials are needed to further define this benefit-risk ratio,” writes the unnamed reviewer.
The FDA on Tuesday will ask a panel of outside experts to weigh in on whether Crestor use should be expanded. The agency is not required to follow the group’s advice, though it often does.
The panel also will discuss 13 deaths due to gastrointestinal disorders seen in Crestor patients, compared with just one in the placebo group. The agency review suggests the higher rate was a “chance finding.”
The FDA also will raise questions about 18 Crestor patients who reported a “confusional state,” compared with four in the placebo group.
AstraZeneca’s Jupiter study focused on patients with lower cholesterol and elevated C-reactive protein, a key indicator of inflammation that can lead to clogged arteries. Under current guidelines, those patients are not recommended for treatment with statins, the best-selling class of cholesterol-lowering drugs.
Patients taking Crestor experienced a 44 percent reduction in major heart problems, including heart attack, stroke and death. It’s unclear whether the positive results seen in Jupiter were due to lower cholesterol or C-reative protein, since Crestor reduces both.
In its own briefing documents, AstraZeneca points out that half of all heart problems occur in patients with normal cholesterol levels, who stand to benefit from expanded use of Crestor.
Broader FDA labeling for the drug would expand the potential U.S. market by at least 6 million patients, according to the FDA. Sales of the drug already rose 30 percent in the last quarter to US$1.15 billion compared with the prior year period.
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