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.


In recent years, Akorn has invested around $23m (€16.3m) in new liquid and lyophilised injectables manufacturing fill line capacity at its Illinois production facility.  In December last year, the US Food and Drug Administration (FDA) completed a pre-approval inspection (PAI) of the plant, clearing Akorn to begin both in-house and contract lyophilisation operations.

Arthur Przybyl, Akorn's CEO, said: "We intend to commercialise our lyophilisation manufacturing capabilities by developing an internal abbreviated new drug application (ANDA) injectable product line and by expanding our contract pharmaceutical manufacturing business segment to include lyophilised injectable products."

The market for contract lyophilisation, a vacuum method for freeze drying compounds that maintains their physical structure, is continuing to expand as drugmakers increasingly turn to industry experts to apply this expensive specialist technique.

While contracting giant Patheon dominates the global scene with its facilities in Ferentino and Monza, Italy and lyophilised cephalosporin plant in Swindon in the UK, the growing demand for improved drug stability means that there are still plenty of opportunities in the market.

Dexamethasone Sodium Phosphate ANDA

In related news, Akorn said it has received FDA clearance for its dexamethasone sodium phosphate injection. The drug, which has an estimated annual market size of $28m according to IMS Health, treats a wide range of conditions including endocrine disorders, arthritis, and blood and dermatologic diseases.

Dexamethasone sodium phosphate was developed by the Akorn-Strides joint venture, which is focused on the development of liquid, lyophilized and dry powder formulations of generic injectable products targeting several therapeutic markets with a major focus on anti-infectives, analgesics and central nervous system (CNS) medicines.

At present, the enterprise has a portfolio of 29 ANDAs and a total of 53 product line offerings. To date, the firm has filed 18 ANDAs with the FDA, 11 of which have been approved.

In its most recent financial statement, Akorn revealed that the joint venture generated revenue in the third quarter of 2008, the majority of which was from sales of its product Rifampin.