Watson Pharmaceuticals Inc (Corona, CA)
Fosamax Tablets (Merck & Co Inc)
February 6, 2008—Watson Pharmaceuticals announced that the company had initiated shipments of the authorized generic of alendronate sodium in the 35- and 70-mg once-weekly dosage strengths, after Fosamax's loss of market exclusivity. Alendronate sodium is indicated for the treatment of osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis. Under the terms of a supply agreement, Merck will manufacture and supply the alendronate sodium tablets to Watson, which will market, sell, and distribute the product in the United States.
Tablets: 35 and 70 mg
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ETHEX Corp (St. Louis, MO)
Tessalon Perles and soft gel capsules (Forest Laboratories)
February 21, 2008—ETHEX Corp announced the approval of Benzonatate Capsules, USP. Benzonatate capsules are indicated for the symptomatic relief of cough. Benzonatate acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough reflex at its source. It begins to act within 15 to 20 minutes, and its effect lasts for 3 to 8 hours.
Fougera, a division of Nycomed US Inc (Melville, NY)
May 6, 2008—Fougera announced that it had received FDA approval to bring to market the first generic Calcipotriene Topical Solution 0.005% (scalp solution). Calcipotriene Topical Solution is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. In order to administer it, the patient should comb the hair to remove scaly debris and, after suitably parting the hair, apply Calcipotriene Topical Solution 0.005% only to the lesions. Rub in gently and completely, taking care to prevent the solution from spreading to the forehead.
Heritage Pharmaceuticals Inc (Edison, NJ)
Nimotop (Bayer AG)
June 15, 2008—Heritage Pharmaceuticals Inc has launched Nimodipine Capsules 30 mg. The product is indicated for the improvement of neurologic outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their postictus neurologic condition (ie, Hunt and Hess grade I-V). This product is an AB-rated, soft-gel capsule and is available in 30- and 100-ct unit-dose blister cartons.
Roxane Laboratories Inc (Columbus, OH), a subsidiary of Boehringer Ingelheim Corp
May 5, 2008—Roxane Laboratories announced FDA approval of its abbreviated new drug application for Ropinirole Hydrochloride Tablets, 0.25, 0.5, 1, 2, 3, 4, and 5 mg. The product is available in bottles of 100. Ropinirole Hydrochloride Tablets are indicated for the treatment of moderate-to-severe primary restless leg syndrome.
In Seniors: Consider CMV Serostatus
When Recommending Flu Vaccine
Older people who have cytomegalovirus seem to have less robust responses to the trivalent influenza vaccine than those who do not have CMV.
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