ANI To Divest Two And Agree To Other Provisions To Close Novitium Deal
Proposed Merger Anticipated To Close This Month Following FTC Settlement
Before closing its acquisition of fellow US-based manufacturer Novitium Pharma, ANI Pharmaceuticals must agree to several orders, including divestment of rights and/or assets for two generic products.
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ANI Pharmaceuticals has completed its acquisition of niche generics specialist Novitium Pharma, securing access to a pipeline of generics and 505(b)(2) candidates that has expanded further since the deal was announced earlier in the year.
A batch of almost three dozen new and revised product-specific guidances for generic products has been published by the US Food and Drug Administration, including for rivals to Primatene Mist (epinephrine) metered-dose inhaler and Spiriva Respimat (tiotropium bromide) inhalation spray.
Hikma has signed another partnership agreement to gain Middle East and North Africa commercialization rights to an ustekinumab biosimilar – although not with its US partner, Bio-Thera Solutions.