FDA has approved alendronate sodium (Binosto, EffRx Pharmaceuticals) effervescent tablets, the first effervescent osteoporosis treatment in a buffered solution.
FDA has approved alendronate sodium (Binosto, EffRx Pharmaceuticals) effervescent tablets, the first effervescent osteoporosis treatment in a buffered solution.
Binosto is previously known as EX101, for the treatment of osteoporosis in postmenopausal women, and as a treatment to increase bone mass in men with osteoporosis. Binosto will be commercially available in the United States in the third quarter of 2012.
Binosto offers those patients who have difficulty with tablets the proven fracture risk reduction of alendronate in an easy-to-swallow buffered solution, Christer Rosén, chairman and CEO of EffRx said in a company press release.
Osteoporosis affects more than 200 million people in the 7 major markets and the global market is estimated to be $10 billion and growing, especially in the emerging markets.
Binosto is a once-weekly, strawberry-flavored effervescent tablet containing alendronate 70 mg that rapidly dissolves in half a glass (4 oz.) of plain room temperature water to make a buffered solution. It is available in packs of 4 and 12 tablets.
Binosto was developed by EffRx based on an agreement with Merck & Co, granting EffRx the worldwide rights to all effervescent and related patents of Fosamax (alendronate). Patents have been granted to EffRx providing exclusivity for Binosto through February 2023. Additional patents are pending.
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
Read More
FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
March 27th 2025Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.
Read More
FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
Read More