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October 24, 2012
06:10 EDTAKRXAkorn announces approval and launch of generic Prometrium
Akorn announced that its manufacturing and development partner, Sofgen Pharmaceuticals has received approval of its abbreviated new drug application, or 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 $170M in the U.S. based on annualizing the three months ended August 31. IMS Health sales figures exclude certain customary discounts and incentives.
News For AKRX From The Last 14 Days
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March 27, 2015
09:50 EDTAKRXAkorn initiated with an Outperform at Avondale
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March 20, 2015
09:34 EDTAKRXAkorn management to meet with William Blair
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07:06 EDTAKRXAkorn launches Phenylephrine HCl Ophthalmic Solution
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March 18, 2015
10:21 EDTAKRXHigh option volume stocks:
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07:32 EDTAKRXAkorn restatement minor, shares attractive, says Jefferies
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07:12 EDTAKRXAkorn shares should recover 'strongly,' says William Blair
William Blair believes shares of Akorn "should recover strongly" with the uncertainty of the annual filing delay being lifted last night. The firm notes management reiterated that the restated financial estimates for 2014 do not affect 2015 guidance. Blair still expects Akorn's 2015 to be a year of "significant cash flow, opportunistic acquisitions, pipeline approvals, and strong growth despite clobetasol competition." It lowered its price target for shares to $58 from $60 and keeps an Outperform rating on the name.
March 17, 2015
19:42 EDTAKRXOn The Fly: After Hours Movers
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16:37 EDTAKRXAkorn to restate Q214, Q314 financial statements
Akorn announced that the company will file its Annual Report on Form 10-K for the year ended December 31 with the U.S. Securities and Exchange Commission on March 17. During the 2014 year-end audit process, an error was identified in the fair value allocation of assets acquired and liabilities assumed in connection with the acquisition of Hi-Tech Pharmacal, which resulted in an overstated chargeback reserve as of April 17. The error, which was identified on March 11, resulted from an overstatement of Hi-Tech's chargeback reserve in connection with applying the acquisition method of accounting at the closing of the Hi-Tech acquisition.The overstatement in the chargeback reserve was caused by a manual error made in preparing the data related to the chargeback reserve whereby there was a duplication of inventory units held by one customer utilized in the calculation of the reserve amount for Hi-Tech products at the acquisition date. The duplication resulted in an overstatement of chargeback reserves by approximately $8.9M for the opening balance sheet of Hi-Tech as of April 17. The chargeback reserve at the end of the quarter ended June 30 was then calculated correctly, resulting in the earlier overstated reserve amount being included in revenue during the quarter ended June 30 . The correction of the error in the quarter ended June 30 resulted in a reduction of previously reported revenue by approximately $8.9M a reduction of previously reported pre-tax income by approximately $8.9M and a reduction of previously reported net income, goodwill and retained earnings by approximately $5.6M, for the company's three and six month periods ended June 30. As a result of that error, the Audit Committee of the Akorn Board of Directors, upon the recommendation of the company's management, concluded that the previously issued financial statements contained in the company's Quarterly Reports on Form 10-Q for the quarters ended June 30 and September 30 should not be relied upon due to an error in the financial statements as of and for the three and six month periods ended June 30 and as of and for the nine month period ended September 30 , and that those financial statements would be restated to make the necessary.
08:34 EDTAKRXInSite Vision announces settlement of lawsuit against Mylan
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