Generic Times Product News

Ifosfamide Injection

Marketed by:

Teva Health Systems, a part of Teva Pharmaceuticals (Irvine, Calif)

Compared to:

Ifex Injection (Bristol-Myers Squibb)

Indication:

July 26, 2007-Teva Health Systems announced the introduction and availability of Ifosfamide Injection. Ifosfamide Injection, used in combination with certain other approved antineoplastic agents, is indicated for third-line chemotherapy of germ cell testicular cancer. It should ordinarily be used in combination with a prophylactic agent for hemorrhagic cystitis, such as mesna. Ifosfamide Injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. It should be administered intravenously at a dose of 1.2 g/m ² per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity.

Dosage Form:

Injection: 3 g/60 mL,1 g/20 mL

For More Information:

www.tevausa.com

Propranolol Hydrochloride Extended-release Capsules

Marketed by:

Actavis Group (Reykjavik, Iceland)

Compared to:

Inderal LA Capsules (Wyeth Pharmaceuticals)

Indication:

August 13, 2007-Actavis Group announced that it received approval from the US FDA to market Propranolol Hydrochloride extended-release (ER) capsules. The product is indicated for the management of hypertension (it may be used alone or used in combination with other antihypertensive agents), long-term management of angina pectoris, and prophylaxis of common migraine headaches. It also is useful in the management of hypertrophic subaortic stenosis, especially for treatment of exertional or other stress-induced angina, palpitations, and syncope.

Dosage Form:

Capsules: 60, 80, 120, and 160 mg

For More Information:

www.actavis.us

Testosterone Enanthate Injection, USP

Marketed by:

Paddock Laboratories Inc (Minneapolis, Minn)

Compared to:

Delatestryl (Indevus Pharmaceuticals Inc)

Indication:

August 2, 2007-Paddock Laboratories announced the launch of Testosterone Enanthate Injection, USP 200 mg/mL, for intramuscular administration. This product is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. These conditions may include primary hypogonadism, hypogonadotropic hypogonadism, or delayed puberty. Testosterone enanthate also may be used secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are 1 to 5 years postmenopausal.

Dosage Form:

Supplied in 5-mL (200 mg/mL) multiple-dose vials; dosage and duration of therapy will depend on age, sex, diagnosis, patient's response to treatment, and appearance of adverse effects.

For More Information:

www.paddocklabs.com 800-328-5113

Verapamil Hydrochloride Extended-release Capsules (PM)

Marketed by:

Mylan Laboratories Inc (Pittsburgh, Pa)

Compared to:

Verelan PM ER Capsules (Elan Drug Delivery Inc)

Indication:

August 10, 2007-Mylan Laboratories announced that Mylan Pharmaceuticals received final approval from the FDA for its abbreviated new drug application for Verapamil Hydrochloride Extendedrelease Capsules (PM), 100, 200, and 300 mg. Verapamil capsules (PM), a calcium channel blocking agent, are indicated for the management of essential hypertension.

Dosage Form:

Capsules: 100, 200, and 300 mg

For More Information:

www.mylan.com www.mylanpharms.com/pdfs/verapamil_hydrochloride.pdf