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

Federal Reserve Struggling to Prevent US Economy from Slumping Like European Economy!

By Glenford S. Robinson The United States Federal Reserve recently took steps to jump-start the …

The Federal Reserve Cut Interest Rate by 25-Basis Points, Wednesday! But Why?

Is the Feds cutting rate because of pressures from President Trump? Or, is the Federal Reserve cutting rate as a result of uncertainties presented by the ongoing trade war between the U.S. and China?

Pre-recession Could be Current State of U.S. Economy, Emotionally!

Defining a recession as two consecutive quarters of negative GDP growth doesn’t tell the whole story of the effect human emotions has on the financial markets. Before there are any consecutive quarters of negative GDP growth, there is the impact of human emotions on the financial markets, which should be taken into consideration. So, by the time two quarters of consecutive GDP growth hits the headlines, investors’ emotions would’ve already nose-dived into depression, dragging down the economy with it. That scenario could be the vampire plaguing the current U.S. economy.

Fed Chairman Powell Signaled US Economy Could Be on Verge of Economic Collapse

Could the US economy be on the verge of an all-out economic collapse? Well, the urgency with which the Federal Reserve Chairman Jerome Powell has acted says exactly that. The Chairman hinted on Friday that the central bank would continue its rate cutting plans started last month (rate cut of 25-basis points).

US Treasury 30-Year Bond Yield Hits Record Low, Economy Heading for Recession?

The infamous inverted yield curve is used to forecast economic recession and it too has shown itself a few times recently, flip flopping its way into the hearts of paranoid investors. The take-away from this is that for a true economic recession to occur, the inverted yield curve must remain inverted for many months to qualify as a true predictor of economic recession.

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.

%d bloggers like this: