Aurobindo Pharma receives USFDA nod for osteoarthritis pain relief drug
Hyderabad-based pharmaceutical manufacturing company Aurobindo Pharma said that it has received the nod from the United States Food and Drug Administration (USFDA) for its topical solution for osteoarthritis pain.
The US drug regulator has given the pharmaceutical major the final approval to manufacture and market Diclofenac Sodium Topical Solution USP, 2 percent w/w, the company said in a filing to stock exchanges.
The approved drug is the bio and therapeutic equivalent of the reference listed drug (RLD) Pennsaid Topical Solution, 2 percent w/w. The RLD is manufactured by Dublin-based Horizon Therapeutics Ireland DAC.
Pennsaid Topical Solution has an estimated market size of $487 million in the US for the 12 months ending December 2022, according to the IQVIA data. The company aims to launch the drug in the first quarter of the upcoming financial year.
The Abbreviated New Drug Application (ANDA) approval for the drug is the first for Aurobindo Pharma’s US step-down subsidiary Aurolife Unit-II, which is located in North Carolina. The plant was set up to manufacture topical products for the pharmaceutical company.
Aurobindo Pharma has now been awarded 430 ANDA approvals (404 Final approvals and 26 tentative approvals) from the USFDA.
The USFDA recently completed the inspection at the company’s wholly owned subsidiary APL HealthCare Ltd’s facilities in Telangana with two observations. The Unit I and III, an Orals (Tablets, Capsules and Soft gel Capsules) and Derma Manufacturing facility, located at Jadcherla, Mahabub Nagar District, were inspected by the USFDA from January 9 to January 18.