The decrease is due to the inability of LEO's API contract manufacturer for Finacea
to meet the required specifications for the finished product, as described above.
Health and wellness company Perrigo Company plc (NYSE; TASE: PRGO) reported on Monday that it has received US Food and Drug Administration tentative approval for the generic version of Finacea
Foam(azelaic acid) 15%.
In January 2013, Glenmark informed Bayer that it had filed the ANDA and claimed that the product would not infringe the patent used for Finacea
. Bayer then filed suit in March 2013, claiming patent infringement.
Bikowski disclosed that he is a consultant to and on the speakers bureau for Intendis Inc., which markets Finacea
Another topical, azelaic acid 15% gel (Finacea
), was approved in 2003 for the inflammatory papules and pustules of mild to moderate rosacea.
In the past year, new drugs have become available, like Finacea
(azelaic acid), which is applied to the skin twice a day.
Recent evidence suggests azelaic acid foam 15% (Finacea
) provides a well-tolerated option with 6.2% of patients experiencing any application site pain, compared with 1.5% on vehicle, she added.
2014 Nov;13[ll]:1380-6), and azelaic acid 15% foam (Finacea
), which also achieved an impressive reduction in inflammatory lesion counts in a phase III trial (Cutis.
M2 PHARMA-August 3, 2015-Bayer HealthCare wins US FDA approval for Finacea
for treating inflammatory papules and pustules of mild to moderate rosacea
In a separate phase IIIb clinical trial, MetroGel significantly outperformed azelaic acid gel 15% (Finacea
) in terms of tolerability.