In January, the U.S. Food & Drug Administration approved indomethacin in an oral suspension, a generic version of Indocin Oral Suspension. The agency also issued a boxed warning and updated label for denosumab, warning of the risks of severe hypocalcemia in patients with chronic kidney disease.
(Reuters Health)—Only 19 U.S. states mandate that pharmacists fill prescriptions for brand-name small molecule drugs with generics when available, with the 31 remaining states allowing but not requiring these substitutions, a new study finds. Researchers examined laws on the books as of September 2019 pertaining to generic substitution of small molecule drugs, as well as…
On April 7, the FDA approved an Abbreviated New Drug Application (ANDA) for Hydroxychloroquine Sulfate Tablets USP, 200 mg, for the treatment of: 1) uncomplicated malaria due to P. falciparum, P. malariae, P. ovale and P. vivax; 2) chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; and 3) treatment of acute and chronic…
(Reuters)—A new not-for-profit supplier of generic drugs formed by a consortium of hospitals systems said it expects this year to be able to provide about 20 products to alleviate shortages of medicines used during surgeries and to treat life-threatening conditions, such as septic shock. Since the start-up of Civica Rx spearheaded by Intermountain Healthcare was…
(Reuters)—The U.S. Food and Drug Administration on Thursday listed drugmakers, including Celgene Corp, Johnson & Johnson, Gilead Sciences and Novartis AG, who the regulator says are potentially blocking access to samples of their drugs to delay generic competition. Generic drugmakers may not be able to develop alternatives without access to samples of branded products they…
It started with an inhaler. Like many of you, I am a rheumatologist. And like you, I see some patients more often their own primary care provider. This is so often the case that I have gradually devolved into their backup, all-purpose doctor. I am the doc they notify when they get hospitalized for pneumonia…
NEW YORK (Reuters)—The head of the U.S. Food & Drug Administration Scott Gottlieb said on Wednesday that he was concerned about the impact of deals like the CVS Health purchase of Aetna Inc. on the ability of pharmaceutical companies to block the entry of cheaper copycat drugs. As the pharmacy benefit managers and the drug…
NEW YORK (Reuters)—A group of four hospital systems plans to launch a not-for-profit generic drugmaker aimed at combating shortages and high costs of some generic drugs, which they blame on unscrupulous drug companies that hike prices. Intermountain Healthcare said on Thursday it was working with three other large U.S.-based hospital systems including Ascension, SSM Health…
(Reuters)—AmerisourceBergen Corp said it expects stubbornly low generic drug prices, which have plagued drugmakers and wholesalers, to not deteriorate further next year, and brushed off concerns about Amazon’s possible entry into the industry. The drug distributor ended its fiscal year with a quarterly loss as it set aside $575 million for legal costs for a…
ZURICH (Reuters)—Swiss drugmaker Novartis is to cut 450 jobs in the United States over the next two years as it gradually shuts a generics manufacturing plant in Colorado and discontinues some products in the face of intense price pressures. “To remain competitive in the U.S., Novartis will discontinue or divest limited growth products in saturated…