FDA Approves Alpharma's KADIAN(R) New 10mg Strength
FORT LEE, N.J., April 23 -- Alpharma Inc., a global specialty pharmaceutical company, today announced that it has been notified by the United States Food and Drug Administration("FDA") that its pending application for KADIAN® 10mg strength capsule has received approval. The company expects to launch this new dosage strength in 2007. This is the second FDA approval for a KADIAN® line extension in 2007. In March 2007, the company received FDA approval for a 200mg dosage strength which was launched in April 2007. KADIAN® is Alpharma's branded extended release morphine sulfate product and is currently marketed in 20mg, 30mg, 50mg, 60mg, 80mg, 100mg and 200mg dosage strengths. KADIAN's wide range of dosage strengths is intended to assist in physicians' efforts to individualize their patient's treatments by offering more choices in managing their pain.
"We are pleased to be able to offer a wide array of KADIAN® dosage strengths to physicians and their patients. We will now have the broadest range of dosage strengths in the long-acting opioid market," commented Dr. Ronald Warner, President of Alpharma's Pharmaceuticals business. "This comprehensive product offering, along with KADIAN's ability to be administered by several routes, provides physicians with considerable flexibility as they select effective solutions to treat their patients' pain."
About KADIAN® Capsules
KADIAN® (morphine sulfate extended-release) Capsules are an extended- release formulation of morphine sulfate indicated for the management of moderate-to-severe chronic pain, when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Capsules can be taken once-daily (q24h) or twice-daily (q12h), as prescribed, to provide up to 24 hours of pain relief. Capsules will now be available in eight strengths: 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 mg and 200 mg. The 100 mg and 200 mg capsules are for use in opioid-tolerant patients only. KADIAN® offers flexible dosing and administration options that allow physicians to fine tune titration schedules and tailor treatment for individual patient needs.
KADIAN® may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression because respiratory depression, abnormally low blood pressure and profound sedation or coma may result.
KADIAN® side effects are generally consistent with those found with other opioids. The most common include drowsiness, constipation, nausea, dizziness and anxiety. Serious adverse reactions that may be associated with KADIAN® include respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, low blood pressure and/or shock.
KADIAN® Capsules contain an opioid agonist which is a Schedule II controlled substance. KADIAN® has an abuse liability similar to other opioids. This should be considered when prescribing or dispensing KADIAN®.
For complete prescribing information, visit http://www.KADIAN.com.
Alpharma Inc. (NYSE: ALO - News) is a global specialty pharmaceutical company with leadership positions in products for humans and animals. Alpharma is presently active in more than 60 countries. Alpharma has a growing branded pharmaceutical franchise in the chronic pain market with its morphine-based extended release KADIAN® product. In addition, Alpharma is among the world's leading producers of several specialty pharmaceutical-grade bulk antibiotics and is internationally recognized as a leading provider of pharmaceutical products for poultry and livestock.