ANI Pharmaceuticals, Inc.
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Latest From ANI Pharmaceuticals, Inc.
AR-15512 missed the primary endpoints in a Phase IIb dry eye disease study that could have served as a pivotal trial, but Aerie’s drug hit enough signs and symptoms of the disease to justify a Phase III.
ANI Pharmaceuticals has announced that the refiled sNDA for its Cortrophin Gel has been accepted by the FDA with a target action date of 29 October 2021. The company said that it was continuing to strengthen its rare disease business leadership team and overall organization to drive the Cortrophin Gel launch preparation.
Teligent is relying upon the FDA approval of its manufacturing capacity at Buena, New Jersey to reintroduce its products in the market and “significantly expand” its production capabilities within the sterile injectables segment.
US-based ANI Pharmaceuticals is looking to strengthen its leadership team and strategize a commercial approach for the launch of Cortrophin Gel, as it anticipates FDA approval by 29 October 2021. ANI reported a 2.4% increase in its generics business.
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