First-Time Generic Approvals: Combunox, Dilantin, Antizol

Jill Taylor

December 28, 2007

December 28, 2007 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for oxycodone hydrochloride and ibuprofen tablets in 5 mg/400 mg strength for the short-term (no more than 7 days) management of acute, moderate to severe pain; extended phenytoin sodium capsules in 30-mg strength for control of generalized tonic-clonic and complex partial seizures and for prevention and treatment of seizures occurring during or following neurosurgery; and fomepizole injectable in 1 g/mL strength for treatment of poisoning with ethylene glycol or methanol.

Generic Oxycodone Hydrochloride and Ibuprofen Tablets (Combunox) for Pain

On November 26, the FDA approved the first generic formulation for oxycodone hydrochloride (HCL) and ibuprofen tablets (generic, Watson Laboratories, Inc; comparable brand, Combunox, Forest Pharmaceuticals, Inc) in 5 mg/400 mg strength for the short-term (no more than 7 days) management of acute, moderate to severe pain.

Pain has been identified at the third leading cause of sick days, accounting for approximately $61.2 billion dollars in lost productivity annually. An estimated 25 million Americans experience acute pain each year.

The medication is supplied in a fixed combination tablet form for oral administration, consisting of the centrally acting opioid agent oxycodone HCL and the nonsteroidal anti-inflammatory agent ibuprofen. The agents have noncompeting analgesic properties.

Generic Extended Phenytoin Sodium Capsules (Dilantin) for Seizures

On December 18, the FDA approved the first generic formulation for extended phenytoin sodium capsules (generic, Wockhardt; comparable brand, Dilantin, Parke Davis) in 30-mg strength for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and for the prevention and treatment of seizures occurring during or following neurosurgery.

Seizures are caused by abnormal electrical activity in the brain, resulting in an involuntary change in movement, sensation, awareness, or behavior. People who have had seizures more than once may be diagnosed with epilepsy, a condition that affects an estimated 2.7 million Americans.

Phenytoin is an antiepileptic drug that appears to act on the motor cortex of the brain, inhibiting the spread of seizure activity. It is not effective for absence (petit mal) seizures and should not be used for seizures resulting from metabolic causes, such as hypoglycemia.

Generic Fomepizole Injectable (Antizol) for Poisoning

On December 14, the FDA approved the first generic formulation for fomepizole injectable (generic, Pharmaforce; comparable brand, Antizol, Jazz Pharmaceuticals, Inc) in 1 g/mL strength as an antidote for ethylene glycol or methanol poisoning or for use in suspected ethylene glycol or methanol ingestion, either alone or in combination with hemodialysis.

Poisoning with ethylene glycol or methanol can be lethal and is considered a medical emergency. Both chemicals are common components in commercial and industrial products, such as antifreeze (ethylene glycol, methanol), windshield washing fluid (methanol), paints and lacquers (ethylene glycol), paint removers (methanol), glass cleaners (ethylene glycol), and certain cosmetic products (ethylene glycol).

Fomepizole is a competitive inhibitor or alcohol dehydrogenase — an enzyme that catalyzes the initial steps in the metabolism of ethylene glycol and methanol to their toxic metabolites.

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