Strides Arcolab Limited has received the US FDA approval for Acarbose tablets, 25mg, 50mg and 100 mg.
Acarbose is a niche anti-diabetic drug used to treat type 2 diabetes mellitus. According to March 2011 IMS data, total US market for Acarbose tablets approximated to USD 21 million with no Indian generic players in the market.
The pharma division has a total of 37 filings with US FDA (21 under the PEPFAR programme and 16 as generics). Approvals to date are 22 (17 under PEPFAR and 5 generics).
This product will be marketed and sold by Perrigo under a profit share partnership. Product is expected to be launched shortly, within Q3 ‘2011.
Acarbose tablets are oral alpha-glucosidase inhibitor for use in the management of type 2 diabetes mellitus. Acarbose tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The drug is contraindicated in patients with known hypersensitivity to the drug and in patients with diabetic ketoacidosis or cirrhosis, in patients with inflammatory bowel disease, colonic ulceration, partial intestinal obstruction. It is available in bottles of 100s in 25mg, 50mg & 100mg.