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January 17, 2019

Teva secures US regulatory approval for generic version of Sabril

Teva Pharmaceuticals USA has secured approval from the US Food and Drug Administration (FDA) for its generic version of Sabril (vigabatrin) drug to treat complex partial seizures, otherwise known as focal seizures.

Teva Pharmaceuticals USA has secured approval from the US Food and Drug Administration (FDA) for its generic version of Sabril (vigabatrin) drug to treat complex partial seizures, otherwise known as focal seizures.

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The indication covers the use of 500mg tablets of the drug as an adjunctive therapy in paediatrics and adults aged ten years and above with inadequate response to various alternative (refractory) therapies.

Sabril is Lundbeck’s branded prescription medication approved in the US in 2009 for the treatment of refractory complex partial seizures (CPS). Teva’s product is the first generic version of the drug.

FDA commissioner Scott Gottlieb said: “Prioritising 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.”

“Prioritising 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.”

Vigabatrin tablets come with a labelled boxed warning for permanent vision loss.

The drug can be prescribed for babies aged one month to two years old with infantile spasms (IS), if the possible benefits outweigh the possible risk of vision loss.

Teva’s generic version is included under a Risk Evaluation and Mitigation Strategy (REMS) programme, which comprises other drug products with vigabatrin to ensure safe use of the medicine.

The most common side effects associated with vigabatrin tablets are dizziness, sleepiness, fatigue involuntary eye movement tremor, blurred vision and memory impairment, among others.

Serious side effects associated with the tablets include permanent vision loss and risk of suicidal thoughts or actions.

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Given the background of high inflation, re-emerging supply chain issues, and the widespread macro-economic implications of the Ukraine conflict, the global pharmaceutical industry is facing an entirely new set of challenges following the turbulence of the COVID-19 pandemic. GlobalData’s World Markets Healthcare (WMH) service has released its latest Q2 forecast. This report incorporates the latest thinking on the opportunities and risks this new environment presents for pharma companies. However, the pharma sector is proving resilient, and we are projecting 4.4% global growth for the year ahead. Yet it remains that the current economic picture is inverting some baseline assumptions from previous quarterly forecasts and altering which markets we expect the key growth levers to derive from. Download our latest executive summary for a snapshot view of what our clients use to formulate winning strategies.
by GlobalData
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