New products for pharmacists: Rx, OTC, and generic (July 2012)


A survey of new Rx, new generic, and new OTC products


New drugs

Pfizer and Protalix BioTherapeutics have announced FDA approval of Elelyso (taliglucerase alfa) for injection as an orphan drug treatment for a form of Gaucher disease. The injectable is a long-term enzyme replacement therapy for patients with type 1, nonneuropathic Gaucher disease, to be administered once every other week by a healthcare professional. Type 1 Gaucher disease is a rare genetic disorder estimated to affect about 6,000 U.S. residents. Patients do not produce enough of the enzyme glucocerebrosidase, which causes a buildup of lipids in the spleen, liver, kidneys, and other organs. Those with the condition may have liver or spleen damage, anemia, low platelet counts, and bone problems. ( / 800-879-3477)

FDA has approved Dymista Nasal Spray for seasonal allergic rhinitis in patients 12 years and older needing treatment with both azelastine hydrochloride and fluticasone proprionate for symptom relief. In clinical studies, Dymista has shown a rapid and more complete symptom relief than standard treatment, according to Meda, a specialty pharmaceutical company in Sweden. ( / +46 709-458 878)

Mission Pharmacal has introduced CitraNatal Harmony, the newest addition to the CitraNatal family of prescription prenatal vitamins. CitraNatal Harmony is the first and only single-dose, prescription prenatal vitamin with calcium citrate, according to the company. Calcium citrate provides critical calcium to help with the baby's bone growth without inducing gas or bloating in the mother. CitraNatal Harmony also offers mother and baby essential vitamins and minerals, including 250-mg of life's DHA, in one gel cap. ( / 800-531-3333)

New generics

FDA has approved generic versions of the blood-thinning drug Plavix (clopidogrel bisulfate), which helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries. Clopidogrel is FDA-approved to treat patients who have had a recent heart attack or stroke, or who have partial or total blockage of an artery (peripheral artery disease). Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharmaceuticals have gained FDA approval for 300-mg clopidogrel. Apotex Corp., Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals have received approval for 75-mg clopidogrel. ( / 888-463-6332)

Sagent Pharmaceuticals has announced the launch of irinotecan injection, the generic form of the chemotherapy drug Camptosar, in two latex-free, preservative-free single-dose vials. Irinotecan hydrochloride injection is an antineoplastic agent of the topoisomerase I inhibitor class. It is indicated in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. ( / 866-625-1618)

Dr. Reddy's has announced the launch of lansoprazole delayed-release capsules in the 15-mg strength in pack sizes of 14, 28, and 42. The drug is a generic version of Novartis' Prevacid 24-HR capsule brand, the over-the-counter drug for treating heartburn. ( / +91-40-49002900)

Actavis Group announced it has received FDA approval for ropinirole extended-release tablets, 2-mg, 4-mg, 6-mg, 8-mg, and 12-mg, a generic equivalent to GlaxoSmithKline's Requip XL. Actavis also has received FDA approval for nifedipine extended-release tablets, USP, 90-mg, a generic equivalent to Bayer's Adalat CC for high blood pressure and chest pain. ( / 973-993-4500)

Greenstone LLC, the U.S.-based generic pharmaceutical subsidiary of Pfizer, has introduced olanzapine tablets to its pharmaceutical product line. The product is the generic equivalent of Zyprexa, and it is available in dosage strengths of 2.5-mg, 5-mg, 7.5-mg, 10-mg, 15-mg, and 20-mg tablets. (

Cipher Pharmaceuticals announced that FDA has approved Absorica, a patented formulation of the acne medication isotretinoin, for the treatment of severe recalcitrant nodular acne. Absorica is expected to launch in the United States in the fourth quarter of 2012. Ranbaxy Laboratories will pay royalties on net sales to Cipher, from whom Ranbaxy has patented the product. ( / 905-602-5840)

Label update

FDA has approved a labeling update for Merck's Isentress (raltegravir) film-coated tablets to include 156-week data from the STARTMRK study with Isentress in combination therapy compared to efavirenz in combination therapy in previously untreated (treatment-naive) adult HIV-1-infected patients. The analyses showed that the regimen containing Isentress demonstrated long-term viral suppression, a greater immunologic response, and a proven safety and tolerability profile at 156 weeks. Isentress is said to be the first and only integrase inhibitor indicated for the treatment of HIV-1 in adult treatment-experienced and treatment-naive patients as part of a combination treatment regimen. It is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. ( / 908-423-1000)

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