page contents
Adobe Stock Photos

Teva Pharmaceutical Stock (TEVA) Trading Higher Today on FDA Approval of Its Seizure Drug Sabril for Adults and Pediatric Epilepsy Patients

FDA News Release

FDA approves first generic version of Sabril to help treat seizures in adults and pediatric patients with epilepsy

For Immediate Release
January 16, 2019

Release
The U.S. Food and Drug Administration approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in patients 10 years and older who have responded inadequately to several alternative (refractory) treatments.

“Prioritizing the approval of generic drugs to compete with medicines that face little or no competition is a key part of our efforts to support access and reduce drug costs to patients. The availability of high-quality generic alternatives of critically important medicines, once the period of patent protection or exclusivity has ended on the brand drug, helps advance access and saves consumers billions of dollars each year,” said FDA Commissioner Scott Gottlieb, M.D. “We know there has been past interest in developing a generic alternative to this product. Earlier this year, we also highlighted this drug, along with many others, on a list of off-patent, off-exclusivity branded drugs without approved generics, to clarify that there were no patents or exclusivities that should impede its approval. Today’s action demonstrates that there is an open pathway to approving products like this one. We’re especially focused on new policies aimed at making the generic review process more predictable, efficient and lower cost so we can entice more generic firms to enter this space, and help facilitate more generic drug launches after generic approvals. We know it’s not enough just to approve a record number of generic medicines. We also want to see firms launch these products so that patients can benefit from their availability, and we intend to take steps to advance these goals.”

Complex partial seizures, a common type of seizures, start in a specific area of the brain and can affect consciousness. Typically, complex partial seizures last between 30 and 90 seconds, and are often followed by a period of disorientation, confusion and/or fatigue.

The FDA requires appropriate data and information to demonstrate that generic drugs meet the agency’s rigorous approval standards to ensure quality drug products that are as safe and effective as their brand name counterparts. As with brand-name drugs, the FDA also inspects manufacturing and packaging facilities for generic drugs to ensure that they are capable of consistently producing quality products.

Labeling for vigabatrin tablets includes a boxed warning for permanent vision loss. Teva’s generic vigabatrin tablets is part of a single shared-system Risk Evaluation and Mitigation Strategy (REMS) program with other drug products containing vigabatrin to ensure safe use of the product. Brand and generic drug makers are required to develop a single shared-system REMS program (unless FDA waives the single shared system requirement) when a generic drug seeks approval and the brand drug has a REMS associated with it.

The most common side effects associated with vigabatrin tablets include dizziness, fatigue, sleepiness (somnolence), involuntary eye movement (nystagmus), tremor, blurred vision, memory impairment, weight gain, joint pain (arthralgia), upper respiratory tract infection, aggression, double vision (diplopia), abnormal coordination and a confused state. Serious side effects associated with vigabatrin tablets include permanent vision loss and risk of suicidal thoughts or actions.

Last year, the FDA began to publish a list of inquiries from generic drug developers seeking the FDA’s assistance in obtaining samples from brand companies, which included Sabril, noting these brand companies were potentially blocking access to the samples of their brand products when the brand products are subject to limited distribution programs, including REMS. The FDA has continued to emphasize that even in the case of limited distribution programs, there should be a path forward for generic drug development. Additionally, the FDA’s list of off-patent, off-exclusivity branded drugs without approved generics is an effort the FDA began in 2017 and will continue to refine and update periodically to ensure continued transparency around drug categories where increased competition has the potential to provide significant benefit to patients.

Today’s approval of generic vigabatrin tablets was granted to Teva Pharmaceuticals USA.

For more information:

FDA: Generic Drugs
FDA: First Generic Drug Approvals
FDA: Drug Competition Action Plan
FDA Tackles Drug Competition to Improve Patient Access
FDA: List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
###

Related Video:

Source

FDA approves first generic version of Sabril to help treat seizures in adults and pediatric patients with epilepsy

The U.S. Food and Drug Administration approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in patients 10 years and older who have responded inadequately to several alternative (refractory) treatments.

Check Also

US Federal Rate cut has come and gone, Now What?

The price of gold has certainly benefitted from the US-China trade war, hitting a six-year high of $1,510. When there are uncertainties in the US dollar and global economy, investors look for safe-haven asset classes to stash their cash. Gold is one of those safe-haven asset classes that investors turn to during times of trouble. In addition, the price of gold is inversely proportional to the price of the US dollar. This means that whenever the price of gold goes up, the price and value of the US dollar goes down. So, as currency traders who trade the USD against other currencies, we should all understand the relationship between the USD and AUX (Gold).

US Interest Rate Cut Sentiment Keeping EUR/USD Above 1.1200

If our prediction holds true, we can expect that the 1.1200 area of support could quickly become an area of resistance all day Thursday, July 25; and may give way Friday a t 8:30 am when US Q2 GDP is expected to come in lower than previous readings.

US Retail Sales Rose, But Building Permits Fall; Fed Rate Cut Decision Pending

The monthly building permit report is watched closely by traders, investors, economists, and by the Federal Reserve. Because all related factors associated with the construction of a building are very important economic activities (for example, financing and employment), the building permit report can give major hints as to the current state of the economy in the not-so-distant future. So, the fact that the latest building permit numbers came in well below estimates, there is cause for concern and the Feds may very will cut interest rate to jump start the economy by putting a cap on the progress of deflation.

US Inflation Rate Fell from 1.8% to 1.6% Giving Strong Indication of a Fed Rate Cut in July

With a strong US dollar, the stock market suffers. This was also one of the reasons why President Donald Trump lashed out at the Feds claiming that the agency was not doing enough to stimulate the economy, condemning the agency for hiking interest rates two times this year, thus stifling the efforts of the US President to stimulate the economy when he championed the passing of legislation which allows huge tax breaks to companies.

communication via hand phone

Global Clinical Alarm Management Market to 2023 with Koninklijke Philips, Vocera, Ascom, Spok, Bernoulli, Connexall, Mobile Heartbeat, GE Healthcare, Capsule Technologie & Masimo Dominating

In 2018, North America is expected to account for the largest share of the global clinical alarm management market. The large share of this region can be attributed to the increasing cases of alarm fatigue and initiatives by government bodies to curtail the effects of alarm fatigue and the increasing need for integrated healthcare IT systems to ensure reliability, efficient maintenance of data, data integrity, and timely availability of patient data to authorized healthcare professionals.

Let your money work for you

SS&C GlobeOp Hedge Fund Performance Index and Capital Movement; IndexSS&C GlobeOp Hedge Fund Performance Index: February performance 1.24%; Capital Movement Index: March net flows advance 0.21%

The SS&C GlobeOp Hedge Fund Performance Index is an asset-weighted, independent monthly window on hedge fund performance. On the ninth business day of each month it provides a flash estimate of the gross aggregate performance of funds for which SS&C GlobeOp provides monthly administration services on the SS&C GlobeOp platform. Interim and final values, both gross and net, are provided in each of the two following months, respectively. Online data can be segmented by gross and net performance, and by time periods. The SS&C GlobeOp Hedge Fund Performance Index is transparent, consistent in data processing, and free from selection or survivorship bias. Its inception date is January 1, 2006.

Image of the US Economy

The Conference Board Leading Economic Index® (LEI) for the U.S. Increased; Economy to Continue Expanding in Near-Term

The ten components of The Conference Board Leading Economic Index® for the U.S. include:Average weekly hours, manufacturingAverage weekly initial claims for unemployment insuranceManufacturers' new orders, consumer goods and materialsISM® Index of New OrdersManufacturers' new orders, nondefense capital goods excluding aircraft ordersBuilding permits, new private housing unitsStock prices, 500 common stocksLeading Credit Index™Interest rate spread, 10-year Treasury bonds less federal fundsAverage consumer expectations for business conditionsFor full press release and technical notes:http://www.conference-board.org/data/bcicountry.cfm?cid=1

%d bloggers like this: