FDA Approved: VIGABATRIN — Original Application (Hikma Pharmaceuticals USA Inc)

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Summary

FDA approved Hikma's generic Vigabatrin under an Original Application (ANDA 213104). This notice confirms approval of a generic Vigabatrin product.

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Diseases / indications

• Epilepsy
• Infantile Spasms
• Tuberous Sclerosis Complex

Drugs mentioned

• Vigabatrin (Vigabatrin)

Snippet

ORIG AP for VIGABATRIN (VIGABATRIN)