Alembic Pharmaceuticals Limited (Alembic) has announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Diclofenac Sodium Topical Solution USP, 2% w/w. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pennsaid Topical Solution, 2% w/w, of HZNP Medicines LLC (HZNP). Diclofenac Sodium Topical Solution USP, 2% w/w is indicated for the treatment of the pain of osteoarthritis of the knee(s).
Diclofenac Sodium Topical Solution USP, 2% w/w, has an estimated market size of US$ 974 million for twelve months ending December 2018 according to IQVIA.
Alembic has a cumulative total of 109 ANDA approvals (96 final approvals and 13 tentative approvals) from USFDA.
Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.552.25 as compared to the previous close of Rs. 566.1. The total number of shares traded during the day was 7794 in over 647 trades.
The stock hit an intraday high of Rs. 576.5 and intraday low of 549. The net turnover during the day was Rs. 4385167.