This site is intended for Healthcare professionals.
×

Alembic Pharma JV Aleor gets tentative USFDA nod for therapeutic equivalent of Pennsaid Topical Solution

................................ Advertisement ................................


business medical dialogues

The approved ANDA(Diclofenac Sodium Topical Solution) is therapeutically equivalent to the reference listed drug product (RLD), Pennsaid Topical Solution, 2% w/w, of HZNP Medicines LLC (HZNP), said Alembic Pharma.

New Delhi: 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 to treat pain of osteoarthritis of the knee(s).

The approved ANDA(Diclofenac Sodium Topical Solution) is therapeutically equivalent to the reference listed drug product (RLD), Pennsaid Topical Solution, 2% w/w, of HZNP Medicines LLC (HZNP), said Alembic Pharma.

................................ Advertisement ................................

Also Read: Alembic Pharma gets USFDA nod for a generic version of Rapaflo Capsules

................................ Advertisement ................................

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.

Headquartered in Vadodara, the company is involved in manufacturing pharmaceutical products, pharmaceutical substances and intermediates.

................................ Advertisement ................................

Also Read: Alembic Pharma gets USFDA nod for a generic version of Jadenu, Exjade tablet to treat chronic iron overload

Spread the love

Author Details

Farhat Nasim

Farhat Nasim joined Medical Dialogues an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

To know about our editorial team click here

Source: self
0 comment(s) on Alembic Pharma JV Aleor gets tentative USFDA nod for therapeutic equivalent of Pennsaid Topical Solution

Share your Opinion Disclaimer

Sort by: Newest | Oldest | Most Voted

    ................................ Advertisement ................................