News: Akorn, Inc. Announces FDA Approval of Diclofenac Sodium …
Akorn, Inc. (NASDAQ: AKRX) today announced that the U.S. Food and
Drug Administration (FDA) has granted approval for Akorn’s Abbreviated
New Drug Application (ANDA) for Diclofenac Sodium Ophthalmic Solution,
0.1%.
Diclofenac Sodium Ophthalmic Solution is a non-steroidal
anti-inflammatory agent used to treat cataract and refractive surgery
patients. Annual sales for Diclofenac Sodium Ophthalmic Solution were
approximately $14 million in 2007, according to IMS sales data.
Arthur S. Przybyl, Akorn’s President and Chief Executive Officer
stated, “We are pleased to announce the ANDA approval for Diclofenac.
This is our first product approval in 2008 for our Somerset, NJ
facility, and represents another important addition to our ophthalmic
product line. We expect to launch Diclofenac in the second quarter of
2008.”
About Akorn, Inc.
Akorn, Inc. manufactures and markets sterile specialty
pharmaceuticals. Akorn has manufacturing facilities located in
Decatur, Illinois and Somerset, New Jersey and markets and distributes
an extensive line of hospital and ophthalmic pharmaceuticals.
Additional information is available at the Company’s website at
www.akorn.com.
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