Login/Register

TWi Pharmaceuticals' ANDA for Dicyclomine Hydrochloride Capsule (equivalent to BENTYL ®) has been officially approved by FDADec 30, 2022

TWi Pharmaceuticals, Inc. (“TWi”) today announced that its ANDA (“Abbreviated New Drug Application”) for Dicyclomine Hydrochloride Capsule (equivalent to BENTYL ®) has been officially approved by US FDA. The Company will start the preparation for launch in the US market accordingly.

Dicyclomine Hydrochloride Capsule are indicated for the treatment of patients with functional bowel/irritable bowel syndrome. According to IQVIA data, the total sales of Dicyclomine Hydrochloride Capsule in the US were approximately US $28 million for the 12 months ended October 2022.