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New branded prescription drugs, new formulations, new indications, generics, OTCs, etc.
Genzyme's Thyrogen (thyrotropin alfa for injection), (617) 252-7500, can now be used in combination with radioiodine to ablate or destroy the remaining thyroid tissue in patients who have had cancerous thyroids removed. Thyrogen was originally approved in 1998 for use as a diagnostic tool for patients being tested for the recurrence of thyroid cancer.
NEW DELIVERY SYSTEM
Amneal Pharmaceuticals, (973) 357-0222, has received FDA approval for bethanechol chloride tablets, USP in 5-, 10-, 25-, and 50-mg strengths under the new expedited approval process. As a generic equivalent to Barr Laboratories' Urecholine, bethanechol chloride is indicated for acute postoperative and postpartum non-obstructive urinary retention and for neurogenic atony of the urinary bladder with retention.
The FDA has approved the application by Caraco Pharmaceutical Laboratories, (318) 871-8400, to manufacture amlodipine besylate in 2.5-, 5-, and 10-mg tablets. Amlodipine is the bioequivalent of Pfizer's Norvasc. Amlodipine is indicated for the treatment of hypertension, the symptomatic treatment of chronic stable angina, and the treatment of confirmed or suspected vasospastic angina.
Teva Pharmaceuticals, (888) 738-2872, has been granted approval to manufacture oxcarbazepine tablets in 150-, 300-, and 600-mg sizes. The medication is the generic equivalent of Trileptal from Novartis and is indicated for use alone or in combination with other medications for the treatment of partial seizures in adults and children four years of age and older.