homemarket Newsstocks News

Alembic Pharma gets USFDA approval for arthritis pain relieve drug

Alembic Pharma gets USFDA approval for arthritis pain relieve drug

2 Min(s) Read

By CNBCTV18.com Dec 1, 2022 3:20:57 PM IST (Published)

The Abbreviated New Drug Application (ANDA) was filed by Aleor Dermaceuticals Ltd., which was amalgamated with Alembic Pharma.

Recommended Articles

View All

Alembic Pharmaceuticals Ltd. on Thursday said that it has received final approval from the United States Food and Drug Administration (USFDA) for Diclofenac Sodium Topical Solution USP 2 percent w/w.
Diclofenac Sodium Topical Solution is used for the treatment of arthritis pain in knees, ankles, feet, elbows, wrists, and hands.
The Abbreviated New Drug Application (ANDA) was filed by Aleor Dermaceuticals Ltd., which was amalgamated with Alembic Pharma. Alembic Pharma completed the acquisition of Aleor Dermaceuticals in March of this year.
Diclofenac Sodium Topical Solution is therapeutically equivalent to the reference listed drug product (RLD), Pennsaid Topical Solution, 2 percent w/w, of Horizon Therapeutics Ireland DAC (Horizon).
According to IQVIA, Diclofenac Sodium Topical Solution USP 2 percent w/w has an estimated market size of $ 512 million in the United States for the 12-month period that ended in September.
Overall, Alembic has received a cumulative total of 177 ANDA clearances comprising 154 final approvals and 23 tentative approvals from the USFDA.
Shares of Alembic are trading 0.18 percent higher at Rs 596.05.
Check out our in-depth Market Coverage, Business News & get real-time Stock Market Updates on CNBC-TV18. Also, Watch our channels CNBC-TV18, CNBC Awaaz and CNBC Bajar Live on-the-go!