Glenmark obtains FDA nod for generic Protopic
Glenmark has received permission from the Food and Drug Administration for Tacrolimus Ointment, 0.03%, the generic of Leo Pharma's Protopic.
Protopic Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable.
[Read more FDA grants Glenmark tentative approval for generic Enstilar]
Glenmark's Tacrolimus Ointment, 0.03%, will be distributed in the United States by Glenmark Pharmaceuticals USA.
Protopic Ointment had a market value of approximately $15.4 million for the 12 month period ending June 2023, per IQVIA.
[Read more: Glenmark expands OTC portfolio with acquisition of Wockhardt’s ANDAs]