Pregabalin Capsule ANDA Approved by U.S. FDA

2019-10-08 16:53
On 30 September 2019, Hainan Shuangcheng Pharmaceuticals Co. Ltd (the “company”) received the notification from the U.S. FDA that the ANDA (abbreviated new drug application) of Pregabalin Capsules submitted has been approved.
Pregabalin is a derivative of the neurotransmitter gamma-aminobutyric acid (GABA), which has analgesic and anticonvulsive effects. Pregabalin has been approved in the U.S. for the following indications: peripheral diabetic neuralgia, post-herpetic neuralgia, adjuvant therapy for adult partial epilepsy, and neuralgia associated with spinal cord injury.
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