Generic Product News

SEPTEMBER 18, 2011

Gemcitabine for Injection
Marketed by:
Dr. Reddy’s Laboratories (Hyderabad, India)
Compared to: Gemzar (Eli Lilly)
Indication: Dr. Reddy’s launched gemcitabine for injection, a bioequivalent generic version of Gemzar. Gemcitabine is indicated both as a single agent and in combination with other cytotoxic chemotherapy drugs for the treatment of a variety of carcinomas. It belongs to the class of drugs known as antimetabolites, which arrest tumor growth by preventing cells from producing DNA and RNA. Gemcitabine is administered intravenously over a period of 30 minutes once weekly. It can be administered for up to 7 consecutive weeks; however, the exact dosing schedule and duration depend on the type of cancer being treated.
Dosage Form: Single-use vials for intravenous injection: 200 mg and 1 g
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Camrese Tablets
Marketed by:
Teva Pharmaceuticals (North Wales, PA)
Compared to: Seasonique (Teva Women’s Health)
Indication: The FDA approved Camrese (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets, an extended-cycle oral contraceptive that is equivalent to Seasonique. Camrese reduces the number of scheduled periods to 4 per year, each lasting approximately 3 days. Patients should be advised not to discontinue taking Camrese in the event of breakthrough bleeding, which is common and tends to decrease over time. The dosage of Camrese is 1 combination levonorgestrel/ethinyl estradiol tablet daily for 84 consecutive days, followed by 1 ethinyl estradiol tablet for 7 days.
Dosage Form: Tablets: 84 containing 0.15 mg levonorgestrel/0.03 mg ethinyl estradiol and 7 containing 0.01 mg ethinyl estradiol only
For More Information:; 888-838-2872

Budesonide Capsules
Marketed by:
Mylan Pharmaceuticals, a subsidiary of Mylan Inc (Pittsburgh, PA)
Compared to: Entocort EC (AstraZeneca)
Indication: Mylan introduced budesonide capsules, the first generic version of AstraZeneca’s Entocort EC, indicated for the treatment of mild to moderate Crohn’s disease. Budesonide is a glucocorticosteroid that reduces symptoms of acute Crohn’s disease flare-ups, such as abdominal pain and diarrhea, by suppressing the body’s immune response. The recommended dosage for active disease is 9 mg taken daily in the morning for up to 8 weeks. Once symptoms are controlled, a daily dose of 6 mg is recommended to maintain clinical remission of Crohn’s disease for up to 3 months. Patients should be advised to avoid grapefruit and grapefruit juice while taking budesoninde.
Dosage form: Capsules: 3 mg
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Imiquimod Cream 5%
Marketed by:
E. Fougera & Co (Melville, NY), a division of Nycomed US Inc
Compared to: Aldara (Graceway Pharmaceuticals)
Indication: 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.
Dosage Form: Imiquimod Cream 5% is supplied in a box containing 24 single-use packets, each of which contains 250 mg of the cream, equivalent to 12.5 mg of imiquimod.
For More Information:; 800-645-9833

Donepezil HCl Tablets
Marketed by:
Dr. Reddy’s Laboratories (Hyderabad, India)
Compared to: Aricept (Eisai)
Indication: Dr. Reddy’s announced the FDA approval and launch of donepezil HCl tablets, a bioequivalent generic version of Eisai’s dementia drug Aricept. Alzheimer’s disease affects an estimated 5.4 million US patients and accounts for $183 billion in annual costs, according to the Alzheimer’s Association. Donepezil, a cholinesterase inhibitor, is approved to treat symptoms related to memory and cognition at all stages of the disease. Patients should begin with an initial dose of 5 mg, taken once daily at bedtime. Dosage may be increased to 10 mg after 4 to 6 weeks of treatment.
Dosage Form: Tablets: 5 and 10 mg
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Ondansetron Oral Solution
Marketed by:
Amneal Pharmaceuticals
Compared to: Zofran (GlaxoSmithKline)
Indication: The FDA approved ondansetron oral solution, Amneal’s AA-rated, therapeutically equivalent alternative to GlaxoSmithKline’s antiemetic Zofran. Amneal’s product is indicated for the prophylaxis of nausea and vomiting associated with cancer chemotherapy, radiotherapy, and postoperative recovery. It is a selective 5-HT3 receptor antagonist that works by blocking the action of serotonin, the release of which may initiate the vomiting reflex. Ondansetron is administered prior to the treatment or procedure that is likely to cause nausea and vomiting, and may be continued for 1 to 2 days afterwards.
Dosage Form: Oral solution: 4 mg/5 mL
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Letrozole Tablets
Marketed by:
Teva Pharmaceuticals (North Wales, PA)
Compared to: Femara (Novartis)
Indication: Teva’s letrozole tablets, an AB-rated generic that is bioequivalent to Femara, were approved for the treatment of postmenopausal women with breast cancer. Letrozole is a nonsteroidal inhibitor of estrogen synthesis that stops or slows tumor growth by decreasing levels of circulating estrogens. The recommended dose is 2.5 mg, taken either once daily or every other day in patients with cirrhosis or severe hepatic impairment. To manage the risk of fractures or osteoporosis associated with letrozole, monitoring of bone density may be required.
Dosage Form: Tablets: 2.5 mg
For More Information:; 888-838-2872

Phentermine Resin Extended-Release Capsules
Marketed by:
Lannett Company, Inc. (Philadelphia, PA)
Compared to: Ionamin (UCB)
Indication: Lannett Company announced that the FDA approved its phentermine resin extended-release capsules, indicated as a short-term adjunct to exercise, behavioral modification, and caloric restriction in the management of exogenous obesity. Phentermine is approved for patients with an initial Body Mass Index of at least 30, or 27 in the presence of risk factors such as hypertension, diabetes, or hyperlipidemia. The dosage is one capsule daily, taken before breakfast or 10 to 14 hours before bedtime. Because phentermine is related to amphetamines and other stimulants, FDA urges prescribers to consider the possibility of abuse when weighing the risks and benefits of phentermine as part of a weight reduction regimen.
Dosage Form: Extended-release capsules: 15 and 30 mg
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