Generic Product News
NOVEMBER 22, 2010
Zolpidem Tartrate Extended- Release Tablets, USP
Marketed by: Actavis (Morristown, NJ)
Compared to: Ambien (sanofi-aventis)
Indication: Actavis was granted FDA approval and 180- day market exclusivity for Zolpidem Tartrate Extended- Release Tablets, USP, a generic version of Ambien. The product is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and maintenance. Dosage should be individualized; however, a standard dose is 12.5 mg taken once daily, immediately before bedtime. Patients should be monitored for the first week of treatment; if insomnia does not remit after 7 to 10 days, the patient may need to be evaluated for an unrecognized psychiatric or physical disorder.
Dosage Form: Tablets: 6.25 mg
For More Information: www.actavis.us; 973-993-4500
Pramipexole Dihydrochloride Tablets
Marketed by: Sandoz Inc (Princeton, NJ) Compared to: Mirapex (Boehringer Ingelheim Pharmaceuticals Inc) Indication: Sandoz announced the launch of pramipexole dihydrochloride tablets, a generic version of Boehringer Ingleheim’s Mirapex. Pramipexole dihydrochloride is a nonergot dopamine agonist indicated for the treatment of signs and symptoms of idiopathic Parkinson’s disease. Pharmacists should be aware of the medication’s potential sedating effects, which may cause patients to fall asleep during activities of daily life.
Dosage Form: Tablets: 0.125, 0.25, 0.5, 0.75, 1, and 1.5 mg
For More Information: www.us.sandoz.com; 609-627-8500
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Oral Suspension
Marketed by: Par Pharmaceutical (Woodcliff Lake, NJ) Manufactured by: Tris Pharma Inc (Monmouth Junction, NJ) Compared to: Tussionex (UCB Manufacturing Inc) Indication: Tris Pharma Inc, in partnership with Par Pharmaceuticals, announced the final FDA approval of the first generic equivalent to UCB’s Tussionex. Hydrocodone polistirex and chlorpheniramine polistirex (CIII) extendedrelease (ER) oral suspension is indicated for the relief of cough and upper respiratory symptoms from allergy or cold in adults and children 6 years and older. Each 5-mL dose contains the equivalent of 10mg of hydrocodone bitartrate and 8 mg of chlorpheniramine maleate, and provides relief for up to 12 hours. Patients should be reminded to use approved measuring devices when administering doses and to avoid operating machinery or driving while taking the medication.
Dosage Form: Oral Suspension
For More Information: www.trispharma.com; 732-940-2800; www.parpharm.com; 201-802-4000 PT
Amlodipine Besylate/Benazepril Capsules
Marketed by: Watson Pharmaceuticals Inc (Morristown, NJ) Compared to: Lotrel (Novartis) Indication: Watson Laboratories Inc, a subsidiary of Watson Pharmaceuticals Inc, launched Amlodipine Besylate/Benazepril capsules, the generic equivalent to Novartis’ Lotrel. Indicated for the treatment of hypertension, the capsules contain a combination of 2 medications, a calcium channel blocker and an angiotensinconverting enzyme inhibitor. Amlodipine Besylate/ Benazepril should not be taken during pregnancy, or by patients with a history of angioedema or severe kidney problems.
Dosage Form: Capsules: Amlodipine Besylate/Benazepril 5/20, 10/20, 2.5/10, and 5/10 mg
For More Information: www.watson.com; 973-355-8300