Generic Product News
Paddock Laboratories (Minneapolis, MN)
Compared to: Sanctura (Allergan)
Indication: Paddock Laboratories announced the FDA approval of trospium chloride tablets, the AB-rated generic equivalent to Allergan’s Sanctura. Trospium chloride is an antispasmodic, antimuscarinic agent indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. A typical dosage is 20 mg, taken twice daily at least 1 hour before meals, or on an empty stomach. Paddock’s product is supplied in 60-count bottles of 20-mg film-coated tablets. Dosage Form: Tablets: 20 mg
For More Information: www.paddocklabs.com; 800-328-5113
Sandoz Inc (Princeton, NJ)
Compared to: Prevacid SoluTab (Takeda Pharmaceuticals)
Indication: Sandoz launched lansoprazole delayedrelease orally disintegrating tablets, an authorized generic version of Prevacid SoluTab. Lansoprazole is a proton pump inhibitor indicated for the treatment of active duodenal and gastric ulcers, as well as heartburn, erosive esophagitis, and other symptoms of gastroesophageal reflux disease. The tablets, available in strengths of 15 and 30 mg, dissolve on the tongue in less than 1 minute and can be taken with or without water.
Dosage Form: Orally disintegrating tablets: 15 and 30 mg
For More Information: www.us.sandoz.com; 609-627-8500
CNS Therapeutics (St. Paul, MN)
Compared to: Lioresal Intrathecal (Marketed by Medtronic; Manufactured by Novartis)
Indication: The FDA recently approved Gablofen (baclofen injection), an intrathecal muscle relaxant marketed by CNS Therapeutics. Baclofen injection is indicated for the long-term management of severe spasticity caused by spinal and cerebral conditions, such as multiple sclerosis, cerebral palsy, spinal cord injury, brain trauma, and stroke. Gablofen is compatible with Medtronic’s SynchroMed II drug pumps, and is offered in the same concentrations as Lioresal Intrathecal, a drug manufactured by Novartis and marketed by Medtronic. Patients and caregivers should be educated on the early symptoms of baclofen withdrawal, which can cause severe adverse effects.
Dosage Form: Syringe: 50 mcg/mL; Vials: 500 mcg/mL, 2000 mcg/mL
For More Information: www.gablofen.com; 651-207-6959 90
Roxane Laboratories, a subsidiary of Boehringer Ingelheim (Columbus, OH)
Compared to: Opana (Endo Pharmaceuticals)
Indication: Roxane Laboratories introduced Oxymorphone Hydrochloride (HCl) tablets, an AB-rated generic version of Opana. Oxymorphone HCl tablets are a semisynthetic opioid analgesic indicated for the relief of moderate to severe acute pain when the use of an opioid is appropriate. Patients taking the medication should be advised of its potential to cause dependency, as well as its interactions with alcohol, antihistamines, and other central nervous system depressants. Roxane’s generic version is available in 100-count bottles of either 5- or 10-mg tablets.
Dosage Form: Tablets: 5 and 10 mg
For More Information: www.roxane.com; 800-962-8364