Akorn Announces Approval of Generic Prometrium
Akorn (NASDAQ: 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.