Marketed by: Sandoz (Princeton, NJ)
Compared to: Yasmin (Bayer)
Indication: Sandoz introduced Syeda (drospirenone 3 mg/ethinyl estradiol 0.03 mg) tablets, the fourth product in a line of oral contraceptives launched by the generic drug maker this year. Equivalent to Bayer’s Yasmin, Syeda is indicated for the prevention of pregnancy in women who choose it as a method of contraception. Patients taking Syeda should be counseled not to smoke, as smoking increases the risk of serious cardiovascular side effects from oral contraceptives. Syeda is supplied in a dosage regimen identical to that of Yasmin.
Dosage Form: 21 active tablets containing 3 mg drospirenone and 0.03 mg ethinyl estradiol; 7 inactive tablets
For More Information: www.us.sandoz.com; 609-627-8500
Nitrofurantoin Oral Suspension
Marketed by: Amneal Pharmaceuticals (Bridgewater, NJ)
Compared to: Furadantin (Shionogi Pharma)
Indication: Amneal received FDA approval to manufacture Nitrofurantoin Oral Suspension, an AB-rated, 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
For More Information: www.amneal.com
Oxymorphone HCl Tablets
Marketed by: Roxane Laboratories, a subsidiary of Boehringer Ingelheim (Columbus, OH)
Compared to: Opana (Endo Pharmaceuticals)
Indication: Roxane Laboratories introduced Oxymorphone 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
Amlodipine Besylate and Benazepril HCl Capsules
Marketed by: Lupin Pharmaceuticals, Inc (Baltimore, MD)
Compared to: Lotrel (Novartis)
Indication: Lupin Pharmaceuticals, Inc received final FDA approval on July 6, 2011, for its Amlodipine Besylate/Benazepril HCl 5-mg/40-mg and 10-mg/40-mg capsules. This approval completes the product line, as the company was granted final approval for Amlodipine/ Benazepril 2.5-mg/10-mg, 5-mg/10-mg, 5-mg/20-mg, and 10-mg/20-mg capsules in February 2010. Lupin’s Amlodipine/Benazepril capsules are the AB-rated generic equivalent of Novartis’ Lotrel capsules, and are indicated for the treatment of hypertension.
Dosage Form: Capsules, amlodipine/benazepril: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 10 mg/20 mg, 5 mg/40 mg, and 10 mg/40 mg
For More Information: www.lupinpharmaceuticals.com; 866-587-4617
Marketed by: Camber Pharmaceuticals Inc (Piscataway, NJ) Compared to: Robaxin (UBC Inc)
Indication: Methocarbamol Tablets USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. Because methocarbamol may possess a general central nervous system (CNS) depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants. Methocarbamol Tablets USP are available in 500 and 700 mg in 100-count and 500-count bottles. For the 500-mg strength, the initial adult dosage is 3 tablets 4 times daily, with a maintenance dosage of 2 tablets 4 times daily. For the 750- mg strength, the initial adult dosage is 2 tablets 4 times daily with a maintenance dosage of 1 tablet every 4 hours or 2 tablets twice daily.
Dosage Form: Tablets: 500 and 750 mg
For More Information: www.camberpharma.com
Marketed by: Greenstone (Peapack, NJ)
Compared to: Aromasin (Pfizer)
Indication: Pfizer’s generic subsidiary Greenstone introduced exemestane tablets, the authorized generic of the breast cancer drug Aromasin. Exemestane is an aromatase inhibitor indicated for the treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have completed a 2-to-3-year course of tamoxifen therapy. It is also used to treat advanced breast cancer in women whose diseased progressed after undergoing treatment with tamoxifen.
Dosage Form: Tablets: 25 mg
For More Information: www.GreenstoneLLC.com
Imiquimod Cream 5%
Marketed by: E. Fougera & Co, a division of Nycomed US Inc (Melville, NY)
Aldara (Graceway Pharmaceuticals)
E. Fougera & Co announced that it received first generic approval from the FDA for Imiquimod Cream 5%, Imiquimod Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults; biopsy-confirmed, primary superficial basal cell carcinoma in immunocompetent adults—maximum tumor diameter of 2.0 cm on trunk, neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured; and external genital and perianal warts/condyloma acuminata in patients 12 years of age or older.
For More Information: www.fougera.com; 800-645-9833
Pantoprazole Delayed Release Tablets
Marketed by: Wockhardt (Parsippany, NJ)
Compared to: Protonix (Pfizer/Wyeth Pharmaceuticals)
Indication: Wockhardt announced the FDA approval and launch of Pantoprazole Delayed Release Tablets, a generic version of Protonix. Pantoprazole is a proton pump inhibitor indicated for the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD). It is also indicated to maintain healing of erosive esophagitis, to reduce relapse rates of heartburn symptoms in patients with GERD, and to treat pathological hypersecretory conditions, including Zollinger-Ellison syndrome. For short-term treatment, the recommended dosing schedule is 40 mg, taken once daily for up to 8 weeks. If adult patients have not healed within 8 weeks, an additional 8-week treatment course may be considered.
Dosage Form: Tablets: 20 and 40 mg
For More Information: www.wockhardt.com
Valacyclovir HCl Tablets
Marketed by: Actavis (Morristown, NJ)
Compared to: Valtrex (GlaxoSmithKline)
Indication: Actavis received FDA approval to market Valacyclovir HCl Tablets, the generic equivalent to GlaxoSmithKline’s Valtrex caplets. Valacyclovir HCl Tablets are a nucleoside analogue DNA polymerase inhibitor indicated to treat and suppress episodes of genital herpes and reduce transmission of the disease. They are also indicated for the treatment of herpes zoster, or shingles, in adult patients, as well as cold sores (herpes labialis) in both adult and pediatric patients. Patients taking Valacyclovir HCl Tablets should be reminded that it is a suppressive therapy that does not cure herpes infections.
Dosage Form: Tablets: 500 and 1000 mg
For More Information: www.actavis.com
Marketed by: Dr. Reddy’s Laboratories (Hyderabad, India)
Compared to: Levaquin (Daiichi Sankyo)
Indication: Dr. Reddy’s announced the FDA approval and launch of levofloxacin tablets, a bioequivalent generic version of Levaquin tablets. Levofloxacin is a fluoroquinolone antibacterial used to treat infections of the skin, sinuses, kidneys, bladder, and prostate. It is also indicated for patients with bacterial infections that cause pneumonia and bronchitis, as well as patients who have inhaled anthrax. Like other fluoroquinolones, levofloxacin carries a boxed warning alerting patients of the increased risk of tendinitis and tendon rupture. This risk is higher in patients older than 60 years, those taking corticosteroid drugs, and those with kidney, heart, or lung transplants.
Dosage Form: Tablets: 250, 500, and 750 mg
For More Information: www.drreddys.com
Doxycycline Hyclate Delayed Release Tablets
Marketed by: Global Pharmaceuticals, a division of Impax Laboratories (Hayward, CA)
Compared to: Doryx (Warner Chilcott)
Indication: Impax Laboratories announced the FDA approval of Doxycycline Hyclate Delayed Release Tablets, a generic version of Warner Chilcott’s Doryx. The product will be launched through Global Pharmaceuticals, Impax’s generic division. Doxycycline is a tetracycline-class antibacterial indicated for rickettsial infections; sexually transmitted infections; respiratory tract infections; specific bacterial infections; ophthalmic infections; anthrax, including inhalational anthrax (postexposure); alternative treatment for selected infections when penicillin is contraindicated; adjunctive therapy in acute intestinal amebiasis and severe acne; and prevention of malaria. Patients taking doxycycline tablets should be advised to drink plenty of fluids with each dose and avoid excessive exposure to sunlight.
Dosage Form: Tablets: 75 and 100 mg
For More Information: www.globalphar.com; 510-476-2000
Levofloxacin Oral Solution
Marketed by: Hi-Tech Pharmacal Co Inc (Amityville, NY)
Compared to: Levaquin Oral Solution (PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals) Indication: Hi-Tech Pharmacal’s Levofloxacin Oral Solution is an AA-rated generic equivalent to PriCara’s Levaquin Oral Solution. Levofloxacin Oral Solution is a fluroquinolone antibacterial indicated for patients 18 years or older with infections caused by designated, susceptible bacteria. The typical dosage is 250, 500, or 750 mg administered orally every 24 hours, depending on the infection being treated. Dosage adjustments are necessary in patients with impaired renal function (creatinine clearance <50 mL/min). Fluroquinolones, including Levofloxacin Oral Solution, are associated with an increased risk of tendonitis and tendon rupture, and may exacerbate muscle weakness in patients with myasthenia gravis.
Dosage Form: Oral solution: each mL contains 25 mg of levofloxacin. Levofloxacin Oral Solution 25 mg/mL is available in multiple sizes—480 mL, 200 mL, and 100 mL.
For More Information: www.hitechpharm.com
Triamcinolone Acetonide Nasal Spray
Marketed by: Teva Pharmaceuticals (North Wales, PA)
Compared to: Nasacort AQ (sanofi-aventis)
Indication: Teva launched triamcinolone acetonide nasal spray, an AB-rated generic version of Nasacort AQ. Triamcinolone acetonide is a corticosteroid indicated for the treatment of nasal symptoms of allergic rhinitis in adults and children 6 years and older. The starting and maximum dose for adults and adolescents 12 years and older is 220 mcg per day. For children aged 6 to 12 years, the starting dose is 110 mcg per day, which may be increased to 220 mcg. Patients should be advised to use the spray on a regular once-daily basis for optimal effect.
Dosage Form: Nasal spray: 16.5-g bottle containing 120 actuations, each delivering 55 mcg triamcinolone acetonide
For More Information: www.tevausa.com; 888-838-2872
Minocycline HCl Capsules
Marketed by: Ranbaxy Pharmaceuticals Inc (Jacksonville, FL)
Compared to: Minocin (Triax Pharmaceuticals LLC)
Indication: Minocycline HCl capsules are Ranbaxy’s AB-rated generic equivalent of Minocin from Triax Pharmaceuticals. Minocycline HCl is indicated for the treatment of infections caused by susceptible bacteria, and can be useful adjunctive therapy for severe inflammatory acne. Minocycline HCl is contraindicated in patients who are hypersensitive to any of the tetracyclines. Patients should be advised to continue taking the drug as directed throughout the full course of therapy.
Dosage Form: Capsules: 50, 75, and 100 mg
For More Information: www.ranbaxy.com; 1-888-RANBAXY
Tamsulosin HCl Capsules USP
Marketed by: Zydus (Pennington, NJ)
Compared to: Flomax (Boehringer Ingelheim Pharmaceuticals)
Indication: Tamsulosin HCl capsules USPare an alpha1-adrenoceptor antagonist indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia. Tamsulosin HCI capsules are not indicated for the treatment of hypertension. The dosage is 0.4 mg once daily taken approximately one half hour following the same meal each day. This dose can be increased to 0.8 mg once daily for patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing. If discontinued or interrupted for several days, therapy should start again with the 0.4-mg once-daily dose.
Dosage Form: Capsules: 0.4 mg
For More Information: www.zydususa.com
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