ALEOR DERMA gets USFDA nod to market medicine to treat knee pain

VADODARA (BARODA) | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Vadodara (Baroda) headquartered pharmaceutical products manufacturing company Alembic Pharmaceuticals Ltd said of its joint-venture company Aleor Dermaceuticals having got USFDA nod to market medicine to treat knee pain.

In a press-release as submitted by the company to the Indian Bourses, titled – “Alembic Pharmaceuticals announces its joint venture Aleor Dermaceuticals received USFDA Tentative Approval for Diclofenac Sodium Topical Solution USP, 2% w/w,” it further read that, Alembic Pharmaceuticals Limited (Alembic) today 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.

To read more, please CLICK here.


Follow DATELINE GUJARAT On :-

FacebookGoogle+LinkedinTwitterYouTube, Blogspot, Telegram, Instagram 


SHARE THIS NEWS ON :-

Do NOT follow this link or you will be banned from the site!