Drugs
FDA says it will not object to certain manufacturers temporarily distributing rifampin containing 1-methyl-4-nitrosopiperazine (MNP) or rifapentine containing 1-cyclopentyl-4-nitrosopiperazine (CPNP) above the acceptable intake limits to avoid shortages while the companies work to reduce or eliminate the impurities. An agency drug safety statement says
Drugs
FDA says it is removing a Boxed Warning about amputation risk on Janssen’s diabetes drug canagliflozin’s (Invokana, Invokamet, Invokamet XR) prescribing information. The agency required the warning in 2017 based on its assessment that the risk of amputations was very serious when considering canagliflozin’s benefit. “Subsequent FDA
Drugs
CDER has issued a Manual of Policy and Procedures (MAPP), Transfer of Ownership, detailing how the Orange Book staff in the Office of Generic Drugs (OGD) will process requests submitted by former and new owners of drug applications to transfer drug application ownership. The MAPP says OGD is responsible for
Drugs
A 1/8-1/23 FDA inspection at Custom Nutraceuticals, Commack, NY, found significant violations of current good manufacturing practice regulations for dietary supplements, rendering the firm’s products to be adulterated. An 8/6 Warning Letter says the agency has not received a response from the firm concerning the
Drugs
FDA has approved Recordati Rare Diseases’ Cystadrops (cysteamine ophthalmic solution) 0.37%, a viscous eye drop solution that depletes corneal cystine crystal deposits in people living with cystinosis. The company says that Cystadrops demonstrated a significant reduction in cystine crystal deposits in the cornea of the eye and is the
Drugs
Dusa Pharmaceuticals, a Sun Pharmaceutical subsidiary, has agreed to pay $20.75 million to the U.S. to resolve allegations raised in a whistleblower lawsuit that it caused doctors to submit false claims to Medicare and the Federal Employee Health Benefit Program by knowingly promoting an administration process for the
Drugs
A 2/10-2/19 FDA inspection at a Wintac Limited drug manufacturing facility in Bangalore, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 8/13 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a
Drugs
FDA commissioner Stephen Hahn has walked back his interpretation of data that supported the agency’s recent decision to grant an emergency use authorization (EUA) for Covid-19 convalescent plasma and its use in treating hospitalized Covid-19 patients (see earlier story). Hahn was widely criticized for misleadingly stating that
Drugs
AbbVie says it has submitted an application to FDA for a new indication for its Rinvoq (upadacitinib) 15 mg once daily to treat adult patients with active ankylosing spondylitis. A company statement says the application is supported by data from a Phase 2/3 study in which Rinvoq demonstrated significant
Drugs
A new FDA study of 252 difficult-to-make prescription pharmaceuticals found that the U.S.-marketed products “consistently meet quality standards even when manufactured outside the U.S.” Published in the Journal of the American Medical Association Network Open, the study found that all 252 drug products the agency
Drugs
FDA says it is delaying collection of new drug manufacturing data to help it track potential drug shortages until an electronic data submission portal is established, which will not be ready by the 9/23 target date. The new reporting requirements are mandated under section 3112(e) of the Coronavirus
Drugs
Amid a swirl of Trumpian controversy, FDA 8/23 issued an emergency use authorization (EUA) for Covid-19 convalescent plasma (CCP) and its use in treating hospitalized Covid-19 patients. Many FDA watchers are calling out FDA commissioner Stephen Hahn for misleadingly stating that 35% of those treated with plasma
Drugs
FDA has issued Tricida a complete response letter on its NDA for veverimer, a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease. The letter requested additional data beyond the TRCA-301 and TRCA-301E trials involving the “magnitude and durability of the
Drugs
CBER director Peter Marks says he would resign if the Trump Administration interfered in an approval decision to speed up access to Covid-19 vaccines. Marks told Reuters that so far he has not felt any political pressure and that the agency will be guided by science alone. Should that
Drugs
FDA has cited Living Senior, Las Vegas, NV, over its www.blueribbonhemp.com Web site that markets CBD products for treating Covid-19 patients. An 8/19 Warning Letter took issue with several claims made on the Web site that promote its CBD products for fighting viral infections like Covid-
Drugs
Bayshore Pharmaceuticals is recalling one lot of metformin hydrochloride extended-release tablets USP, 500 mg, 1,000 count bottles and one lot of 750 mg, 100 count bottles due to the detection of N-nitrosodimethylamine (NDMA) levels above the agency’s acceptable daily intake limit. NDMA is classified as a
Biologics
Interviewed on WILX in Lansing, MI, FDA commissioner Stephen Hahn continued his efforts to reassure the public that there has been no political pressure on FDA to speed a vaccine approval and that only scientific data will be used to make such a decision. He reiterated that the speed in
Drugs
FDA has approved a Novartis NDA for Kesimpta (ofatumumab) for subcutaneous use to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The drug is described as a targeted, precisely dosed and delivered B-cell therapy that can be self-
Drugs
FDA says it has approved changes to labeling for hydrochlorothiazide (HCTZ) to inform healthcare professionals and patients about a small increased risk of non-melanoma skin cancer associated with HCTZ use. The changes also encourage patients to protect their skin from the sun, an agency notice says. The overall risk
Drugs
FDA has approved a Janssen Biotech supplemental BLA for the use of Darzalex (daratumumab) in combination with Amgen’s Kyprolis (carfilzomib) and dexamethasone for relapsed/refractory multiple myeloma in those who have received one to three previous therapies. Approval was based on data from the Phase 3 CANDOR study that
Drugs
The dietary supplement industry reportedly is concerned about recent Warning Letters to several dietary supplement manufacturers that said N-acetylcysteine (NAC) is excluded from the definition of a dietary supplement because it was first approved as a drug in 1963. Natural Products Insider says in an online post that the
Drugs
FDA has temporarily put the brakes on an emergency use authorization (EUA) for using blood plasma therapy for treating Covid-19 patients until more data are presented to demonstrate its effectiveness, according to several media reports. NIH director Francis Collins and National Institute of Allergy and Infectious Diseases director Anthony