Generic Products

Pharmacy TimesJune 2011 Women's Health
Volume 77
Issue 6


Marketed by: Sandoz (Princeton, NJ)

Compared to: YAZ (Bayer)

Indication: Sandoz recently added Loryna (drospirenone and ethinyl estradiol) tablets to its growing portfolio of generic oral contraceptives (OCs). Loryna is one of just 2 generic versions of YAZ, Bayer’s combination OC. According to the Centers for Disease Control and Prevention, 28% of contraceptive users choose OCs, which are the most commonly used form of contraception. In addition to the prevention of pregnancy, Loryna is indicated for the treatment of moderate acne in women 14 years and older who choose OCs as a method of birth control. It is supplied in a 28-day dosage regimen identical to that of YAZ.

Dosage Form: 24 active tablets containing 0.3 mg drospirenone/0.02 mg ethinyl estradiol; 4 inactive tablets

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Nitrofurantoin Oral Suspension

Marketed by: Amneal Pharmaceuticals (Bridgewater, NJ)

Compared to: Furadantin (Shionogi Pharma)

Indication: Amneal announced that it received FDA approval to manufacture nitrofurantoin oral suspension, an ABrated, therapeutically equivalent alternative to Furadantin. Amneal is the first to market a generic version of the antibacterial medication, which is indicated for the treatment of urinary tract infection. The recommended dosage for adults is 50 to 100 mg taken 4 times daily with food. Therapy should continue for 1 week, or at least 3 days after bacteria is no longer present in the urine. Patients treated with nitrofurantoin are predisposed to persistence or reappearance of bacteriuria, and should be tested before and after completion of therapy to ensure eradication.

Dosage Form: Oral suspension: 25 mg/5 mL

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Epinastine HCl Ophthalmic Solution, 0.05%

Marketed by: Cypress Pharmaceutical

Compared to: Elestat (Allergan)

Indication: Cypress launched epinastine HCl ophthalmic solution, 0.05%, a generic equivalent of Allergan’s topical ophthalmic antihistamine, Elestat. As the first company to file an abbreviated new drug application for the product, Cypress was granted 180 days of marketing exclusivity. Epinastine ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis. The recommended dosage is 1 drop in each eye twice a day. Treatment should continue throughout the period of exposure to offending allergens—for example, until pollen season is over— even if symptoms are absent.

Dosage Form: Ophthalmic solution: 0.05%

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Cyclobenzaprine HCl Extended-release Capsules

Marketed by: Mylan Pharmaceuticals, a subsidiary of Mylan Inc (Pittsburgh, PA)

Compared to: Amrix (Cephalon)

Indication: Mylan’s subsidiary Mylan Pharmaceuticals announced the FDA approval and launch of cyclobenzaprine HCl extended-release capsules, the first generic version of the muscle relaxant Amrix. Mylan will have 180 days of exclusivity to market the product, which is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Because adequate evidence of the drug’s effectiveness for long-term use is not available, treatment with cyclobenzaprine should be confined to short periods of up to 2 or 3 weeks.

Dosage Form: Extended-release capsules: 15 and 30 mg

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