The US FDA published another warning letter sent to Akorn, which details cases of improper investigation into faulty batches, failure to exercise controls over data, and ‘poor aseptic behaviour’.
Akorn announces fraud case launched by Fresenius has been denied by US courts, shortly after fourth quarter financials revealed problems within its manufacturing network.
The decision, influenced by the expected loss of exclusivity for Restasis, will allow the company to ‘improve efficiencies’ across its manufacturing network, a spokesperson explained.
The FDA has granted sNDA approval for Akorn’s IC-Green injection dye, which is the first lyophilised product manufacturered at the firm’s Decatur facility to gain such status.
Specialty pharmaceutical company Akorn has signed up with
India-based Cipla in an exclusive manufacturing and supply
agreement for an undisclosed inhaled drug.
Akorn, a US pharmaceutical company that develops, manufactures and
markets branded and generic diagnostics and therapeutics for niche
segments such as ophthalmology, rheumatology and anaesthesia, has
received a warning letter from...