New products: Rx, generic, OTC (March 2009)


A survey of new Rx, new OTC, new indications, and new generics

Key Points


New drugs

Forest Laboratories and Cypress Bioscience announced that Savella (milnacipran HCl), a selective serotonin and norepinephrine dual reuptake inhibitor, was approved by the FDA for the management of fibromyalgia. Studies showed that doses of 100 mg/day and 200 mg/day demonstrated statistically significant and clinically meaningful improvements in pain, patient global assessment, and physical function. Patients should be cautioned about risk of bleeding when milnacipran is used with NSAIDs, aspirin, warfarin, or other drugs that affect coagulation. For more information, visit

Ferring announced the FDA recently approved the injectable drug degarelix, the first new drug in several years for treatment of prostate cancer. Degarelix is intended for patients with advanced prostate cancer. For more information, visit or call 888-337-7464.

New indication

ConvaTec announced that it has received expanded indications from the FDA for its Aquacel and Aquacel Ag hydrofiber dressings for the management of surgical wounds that heal by primary intent. The Aquacel Ag dressing provides the broad-spectrum antimicrobial properties of ionic silver, which kills a broad range of pathogens, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE). For more information, visit

New generics

Actavis Group announced that it has received approval from the FDA to market Levetiracetam Oral Solution. Levetiracetam Oral Solution is available in the 100 mg/mL strength and is the generic equivalent of UCB's Keppra(R) Oral Solution. Levetiracetam Oral Solution is used in the treatment of partial onset seizures in adults and children with epilepsy. More information about Actavis in the United States can be found at

Sun announced it has received final approval from the FDA for several abbreviated new drug applications (ANDAs). Approval was received for generic hydrocodone bitartrate with acetaminophen (APAP) tablets. Approval was also received for pamidronate disodium for injection USP (generic Aredia), gemfibrozil tablets (generic Lopid), and promethazine hydrochloride tablets USP (generic Phenergan). Visit for more information.

Watson announced that its subsidiary, Watson Laboratories, has received final approval from the FDA on its ANDA for Azurette (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP, 0.15 mg / 0.02 mg), the generic equivalent of Duramed's Mircette, a low-dose monthly oral contraceptive product that is indicated for prevention of pregnancy. For more information, visit


McNeil Consumer Healthcare announced the availability of Children's Zyrtec Allergy Bubble Gum Syrup, a new sugar-free, dye-free, bubble-gum-flavored product used to treat perennial and seasonal allergic rhinitis, also known as upper respiratory allergies, in children two years and older. The new children's product is available in original prescription strength without a prescription in local retail stores. Visit for more information.

AgroLabs announced "the newest addition to its collection of liquid nutrition to promote healthier lifestyles," Naturally CranBerry Omega, which provides all the benefits of the cranberry with 300 mg of Omega 3 derived from cranberry seeds. Consumers can find information about CranBerry Omega and other AgroLabs brands by visiting

Carex Health Brands introduced Thera-Med Sinus Headache Cold Pack for the flu and allergy season. Offering highly targeted relief for sinus pain and headaches, the new pack features a soft side for cold and a smooth side for extra cold. For more information, visit

Boiron introduced Sabadil for allergy symptoms. Sabadil's formula contains six active ingredients to address allergy-related problems. It is designed to relieve hay fever and other upper respiratory allergy symptoms, including itchy nose, sneezing, runny nose, and itchy and watery eyes. To learn more, call the Boiron information center at 800-264-7661 or e-mail

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