Akorn Announces Approval of Generic Prometrium

Akorn AKRX today announced that its manufacturing and development partner, Sofgen Pharmaceuticals, LLC, has received approval of its abbreviated new drug application (ANDA) for Progesterone capsules, 100mg and 200mg. The approved ANDA is for the generic of Abbott Laboratories' Prometrium® capsules indicated for the treatment of endometrial hyperplasia and secondary amenorrhea. Akorn has exclusive marketing rights to Sofgen's product in the U.S. and the Company has begun distribution. According to IMS Health, Progesterone capsules, 100mg and 200mg, had combined sales of approximately $170 million in the U.S. based on annualizing the three months ended August 31, 2012. IMS Health sales figures exclude certain customary discounts and incentives. See full press release