JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announces the launch of the generic equivalent to Actonel® (risedronate sodium) Tablets, 5 mg, 30 mg, and 35 mg, in the United States. Teva was first to file, making the product eligible for 180 days of market exclusivity. Risedronate sodium tablets are used to treat or prevent osteoporosis in women after menopause. Risedronate sodium tablets help increase bone mass and help reduce the chance of having a spinal or non-spinal fracture (break). Risedronate sodium tablets are also used to treat or prevent osteoporosis in either men or women who are taking corticosteroid medicines, and to treat Paget’s disease of the bone.
Risedronate sodium tablets, USP are the second approved product to treat osteoporosis in Teva’s generic portfolio. Approximately 54 million Americans have low bone mass and osteoporosis, a condition that causes the bones to become weak and brittle. Anyone can develop osteoporosis but studies suggest it is most common in older women and patients taking specific medications. As a leading global pharmaceutical company, Teva is committed to care in women’s health and bringing to market high-quality, accessible generic medicines for doctors, pharmacists, and most importantly, patients.
Actonel® (risedronate sodium) Tablets marketed by Actavis had annual sales of approximately $157 million in the United States, according to IMS data as of December 2014.
About Risedronate Sodium Tablets, USP
Risedronate Sodium Tablets, USP are indicated for: treatment and prevention of postmenopausal osteoporosis; treatment to increase bone mass in men with osteoporosis; treatment and prevention of glucocorticoid-induced osteoporosis; and treatment of Paget’s disease.
Limitations of use: Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use.
Important Safety Information
Risedronate sodium tablets, USP are contraindicated in patients with: abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia; inability to stand or sit upright for at least 30 minutes; hypocalcemia; or known hypersensitivity to any component of this product. Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
Patients being treated with risedronate sodium delayed-release tablets (Atelvia®) should not receive risedronate sodium tablets, since both drugs contain the same active ingredient.
Risedronate may cause local irritation of the upper gastrointestinal mucosa. Patients with known esophageal diseases, gastritis, duodenitis or ulcers should be carefully evaluated for possible irritant effects and a potential for worsening of the underlying disease. Esophageal adverse experiences, some severe and requiring hospitalization, have been reported. Patients should be instructed to discontinue risedronate and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
Other serious adverse reactions associated with the use of risedronate or other bisphosphonates include: hypocalcemia; osteonecrosis of the jaw; severe and occasionally incapacitating bone, joint, and/or muscle pain; and atypical, low-energy, or low trauma fractures of the femoral shaft and femur.
The most common adverse reactions reported in greater than 10% of patients treated with risedronate and with a higher frequency than placebo are: back pain, arthralgia, abdominal pain, and dyspepsia. Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis), and eye inflammation (iritis, uveitis) have been reported rarely.
Please see accompanying Full Prescribing Information.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva's net revenues in 2014 amounted to $20.3 billion. For more information, visit www.tevapharm.com.
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