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December 16, 2004

FDA Approvals: Omacor, Nuflexxa, Combunox, and Others

Topics: Clinical Pharmacology

Summary of selected recent FDA approvals (Medscape Medical News, Dec. 9, 2004)

The U.S. Food and Drug Administration (FDA) has approved omega-3 acid ethyl esters for the treatment of hypertriglyceridemia; 1% sodium hyaluronate for the second-line treatment of pain associated with osteoarthritis of the knee; a combination tablet of oxycodone and ibuprofen for the short-term treatment of acute moderate to severe pain; intravenous administration of treprostinil sodium; and a 1-g mesalamine suppository for the once-daily treatment of ulcerative proctitis.

Omega-3 Acid Ethyl Esters (Omacor) Reduces High Triglyceride Levels

On Nov. 10, the FDA approved omega-3 acid ethyl esters (Omacor capsules, made by Pronova Biocare AS and marketed in the U.S. by Reliant Pharmaceuticals, Inc.) for use as an adjunct to diet for the treatment of hypertriglyceridemia (levels > 500 mg/dL) in adults.

(...)   The product is the first of its class to be approved by the FDA and contains highly concentrated ethyl esters of eicosapentanoic acid and docosahexaenoic acid. According to a company news release, the proprietary manufacturing process eliminates heavy metals and other environmental pollutants commonly detected in many omega-3 products.

1% Sodium Hyaluronate (Nuflexxa) for Osteoarthritic Knee Pain

On Dec. 7, the FDA approved 1% sodium hyaluronate (Nuflexxa, made by Savient Pharmaceuticals, Inc.) for the treatment of pain associated with osteoarthritis (OA) of the knee when nonpharmacologic therapy and simple analgesics provide inadequate relief. It is the first and only non-avian derived hyaluronic acid approved for this use in the U.S.

The product is approved for use in Europe where it is marketed as Euflexxa.

Oxycodone/Ibuprofen 5 mg/400 mg (Combunox) for Acute Short-term Pain

On Nov. 21, the FDA approved the first and only fixed-dose combination of 5 mg oxycodone and 400 mg ibuprofen (Combunox tablets, made by Forest Laboratories, Inc.), a schedule II product that is indicated for the short-term (no more than seven days) management of acute moderate to severe pain.

IV Administration Approved for Treprostinil (Remodulin)

On Nov. 24, the FDA approved intravenous (IV) administration of treprostinil sodium (Remodulin, made by United Therapeutics Corp.) for the treatment of pulmonary arterial hypertension (PAH) in patients with New York Heart Association class II to IV symptoms to diminish the symptoms associated with exercise.

Once-Daily Mesalamine Suppository (Canasa 1 g) for Ulcerative Proctitis

On Nov. 9, the FDA approved a 1-g dose for mesalamine suppositories (Canasa, made by Axcan Pharma, Inc.) for the once-daily treatment of ulcerative proctitis.

Read related articles and read more details of the above summaries...

Posted by Hyscience at December 16, 2004 9:51 PM



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