Par Pharmaceutical, one of Endo International plc's (NASDAQ: ENDP) operating companies, has started shipping vigabatrin for oral solution USP, 500 mg per packet, it was reported yesterday.
The company has taken this step following final approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application.
The product is the generic version of Lundbeck LLC's Sabril and is the first and presently the only generic version available. It is only available through certified healthcare providers and specialty pharmacies. The oral solution is a prescription medicine used with other treatments in adults and children 10 years of age and older with refractory complex partial seizures (CPS) who have not responded well enough to several other treatments, and where the possible benefits outweigh the risk of vision loss. Vigabatrin should not be the first medicine used to treat CPS.
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