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Akorn (Nasdaq:AKRX), a leading specialty generic pharmaceutical company, announced that, on October 26, 2018, it received a new Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration for Clobetasol Propionate Lotion, 0.05%. As quoted in the press release: This ANDA was filed in December 2017 and therefore was a first cycle …
Akorn (Nasdaq:AKRX), a leading specialty generic pharmaceutical company, announced that, on October 26, 2018, it received a new Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration for Clobetasol Propionate Lotion, 0.05%.
As quoted in the press release:
This ANDA was filed in December 2017 and therefore was a first cycle approval. The product is manufactured at Akorn’s Amityville, New York manufacturing facility.
According to IQVIA, sales of Clobetasol Propionate Lotion, 0.05% were approximately $10.7 million for the twelve months ended August 2018.
Clobetasol Propionate Lotion, 0.05% is a super-high potent topical corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older.