Recently，Food and Drug Administration (FDA) approved SinoT’s ANDA（# 214496）application for PREGABALIN EXTENDED-RELEASE TABLETS（82.5 mg, 165 mg, and 330 mg）
Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA)，and its marketed dosage forms in the US include: capsules、oral solution、 extended-release tablets.
Pregabalin extended-release tablets should be administered once daily and be indicated for the management of :1) Neuropathic pain associated with diabetic peripheral neuropathy (DPN), 2)Postherpetic neuralgia (PHN).
About SinoT
SinoT is a specialty pharma with focus on the research & development, commercialization and sale of complex generics and 505(b2) products. We dedicated to developing high quality medicines that meet with international standards. We’ll do more than our best to benefit the patients in the future.
Shanghai Head Office
Greenland Being Fun Plaza, Bldg. 1, Rm. 207, Pudong New District, Shanghai
Manufacturing Site inJiangsu
No. 163 Zhuhai Road, Haimen Area, Nantong City, Jiangsu Province
