Product approval under the para IV route
Bangalore, July 04, 2018: Strides Shasun Limited today announced that its wholly owned subsidiary Strides Pharma Global Pte. Ltd. has received tentative approval for its Para IV filing of Milnacipran Hydrochloride Tablets, 12.5 mg, 25 mg, 50 mg, and 100 mg from the United States Food & Drug Administration (US FDA). Milnacipran Hydrochloride Tablet is a generic version of Savella® Tablets of Allergan Sales, LLC (Allergan).
As per IQVIA MAT data, the US market for Milnacipran Hydrochloride Tablets is approximately USD 145 Million. The product will be manufactured at the Company’s Oral dosage facility at Puducherry and will be marketed by Strides Pharma Inc. in the US Market. Further updates on commercialization will be provided on receiving the final approval for the product.
The company has 75 cumulative ANDA filings with USFDA of which 51 ANDAs have been approved as of date and 24 are pending approval.
Corporate Comm India(CCI Newswire)