Jubilant gets USFDA nod for epilepsy injection

Drug firm Jubilant Life Sciences has received final approval from the US health regulator for generic Levetiracetam injection, used for treatment of epilepsy, in the American market.  The company has received abbreviated new drug application (ANDA) final approval for Levetiracetam injection USP, 500 mg/5 mL (100 mg/mL) from the United States Food and Drug Administration (USFDA).

The company’s product is the generic version of UCB’s Keppra injection in the same strength. As on March 31, 2016, Jubilant Life Sciences had a total of 739 filings for formulations, of which 517 have been approved in various regions globally. This includes 72 ANDAs filed in the US, of which 44 have been approved and 46 Dossier filings in Europe.

Did You Know?

  • Epilepsy is the fourth most common neurological disorder and affects people of all ages
  • Epilepsy means the same thing as “seizure disorders”
  • Epilepsy is characterized by unpredictable seizures and can cause other health problems
  • Epilepsy is a spectrum condition with a wide range of seizure types and control varying from person-to-person
  • A person is diagnosed with epilepsy if they have one or more seizures that were not caused by some known and reversible medical condition like alcohol withdrawal or extremely low blood sugar.
  • The word “epilepsy” does not indicate anything about the cause of the person’s seizures or their severity.

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