New Rx, OTC, and generics (September 2009)


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

Key Points


New drugs

Daiichi Sankyo and Eli Lilly have announced that the U.S. Food and Drug Administration approved Effient (prasugrel) tablets for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndromes who are managed with percutaneous coronary intervention (PCI). For more information about Effient visit

BioDelivery Sciences International announced that the U.S. Food and Drug Administration has approved Onsolis (fentanyl buccal soluble film) for the management of breakthrough pain in patients with cancer. Onsolis consists of a small soluble polymer film, formulated with the opioid narcotic fentanyl for application to the buccal mucosa. Visit for more information.

New indications

The FDA approved Teva Pharmaceuticals' Plan B One-Step, a single-pill version of the two-pill-dose emergency contraceptive product Plan B, and lowered the limit for over-the-counter purchase of the drug to age 17, Teva announced. For more information, call 888-TEV-AUSA.

New generics

Mylan announced that its subsidiary Mylan Pharmaceuticals has received approval from the FDA for its Abbreviated New Drug Application (ANDA) for liothyronine sodium tablets USP, 5 mcg (base), 25 mcg (base), and 50 mcg (base). Liothyronine sodium tablets are the generic version of King Pharmaceuticals' thyroid deficiency treatment Cytomel.

Mylan also announced that Mylan Pharmaceuticals has received approval from the FDA for its supplemental ANDA for temazepam capsules USP, 22.5 mg. This strength is in addition to Mylan's currently marketed 15 mg and 30 mg product strengths. Temazepam capsules are the generic version of Mallinckrodt's Restoril, a sleep aid. Contact for more information.


Essential Home OTCs launches SymptomPak, a kit that allows users to purchase single-ingredient products to meet any family's cold, cough, fever, flu, and allergy therapy needs. The SymptomPak system contains five individual stock-keeping units (SKUs) featuring the ingredients most often needed for colds, cough, fever, and flu. Developed by a pharmacist, each bottle offers an ingredient for a specific symptom. You use only what you need for the specific symptoms of cold, cough, or flu. Each SKU is refillable individually. for more information, call 941-322-0280 or visit

Swissco offers the new Swissco Suction Cup Mirror, which attaches to most surfaces and can be tucked into a suitcase for travel. This 5-inch flat mirror features 12X magnification and reflects a clear image. Call 212-779-8880 or visit For more information.

Perrigo announced that it has received FDA approval for its OTC coated nicotine polacrilex lozenge, 2 mg and 4 mg, in cherry and cinnamon flavors. The new products will be marketed under store-brand labels and are comparable with GlaxoSmithKline's Commit lozenge, a smoking cessation product. For more information, call 269-673-8451.

Health Enterprises has announced the arrival of its Ear Irrigator, for cleaning ears and helping to prevent buildup of ear wax. The company states that the irrigator will allow consumers to experience the safe and effective ear-cleansing technology used in physicians' offices. The ear irrigator features a patented doctor-designed tip and includes a flared design with tri-stream-spray and exit portals. Visit for more information.

HemCon Medical Technologies announced that its new HemCon nasal plugs and seal-on devices for anterior nasal bleeding are now available for use in both professional and home settings. The nasal-care products will be available to consumers under the Seal-On brand. Call 971-223-4918 for more information.

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