Watson Pharma launches Lipitor generic
Watson Pharma launched the generic version of Pfizer's blockbuster cholesterol-busting drug Lipitor, dubbing it the "largest generic product launch in US history".
Under the terms of the exclusive supply and distribution agreement, Pfizer manufactures and supplies Watson with all dosage strengths of the authorised generic product.
Watson markets and distributes the product in the US," the firm said. Watson has not revealed it’s pricing for the drug, but analysts said it will have to sell the drug at a competitive price. Pfizer has been selling the drug for as low as $4 for 30 days.
Watson's launch raises questions on Ranbaxy Laboratories' revenues from the drug. India's third-largest drug company was scheduled to launch the generic version of the drug on Wednesday, but is struggling to get approvals from the US drug regulator.
Horizon Pharma Announces Launch of DUEXIS (Ibuprofen/Famotidine) in the United States
Horizon Pharma, Inc announced that DUEXIS (ibuprofen/famotidine), a proprietary single-tablet combination of ibuprofen (800 mg) and famotidine (26.6 mg), is now available to U.S. physicians for the relief of signs and symptoms of rheumatoid arthritis (RA) and osteoarthritis (OA) and to decrease the risk of developing upper gastrointestinal (GI) ulcers, which in Phase 3 clinical trials were defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcers. Controlled trials do not extend beyond six months.
In April, the U.S. Food and Drug Administration (FDA) approved Horizon's new drug application (NDA) for DUEXIS. The NDA was supported by data from the pivotal REDUCE-1 and REDUCE-2 clinical studies that enrolled more than 1,500 patients. In REDUCE-1, DUEXIS demonstrated a statistically significant reduction in the incidence of non-steroidal anti-inflammatory drug (NSAID)-induced gastric ulcers versus treatment with ibuprofen alone (8.7% versus 17.6%). In REDUCE-2, DUEXIS demonstrated a statistically significant reduction in the incidence of upper gastrointestinal ulcers versus treatment with ibuprofen alone (10.5% versus 20.0%).
The most common adverse reactions (≥1% and greater than ibuprofen alone) were nausea, diarrhea, constipation, upper abdominal pain and headache. Overall, the discontinuation rate in the REDUCE-1 and REDUCE-2 studies due to adverse events for patients receiving DUEXIS and ibuprofen alone were similar.
According to the Arthritis Foundation, arthritis affects nearly 46 million people in the United States. With the aging of the U.S. population, the prevalence of arthritis is expected to rise by approximately 40% by 2030, impacting 67 million people in the United States.
NSAIDs are effective at providing pain relief associated with OA and RA; however, there are significant upper GI-associated adverse events which can result from such treatments. DUEXIS reduced the risk of ibuprofen-induced upper GI ulcers by approximately 50% in REDUCE-1 and REDUCE-2. Patients with OA and RA on NSAIDs are at increased risk for upper GI ulcers.
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