Drugs
Sen. Claire McCaskill (D-MO), ranking Democrat on the Senate Homeland Security and Governmental Affairs Committee, has asked Purdue, Janssen/Johnson & Johnson, Insys, Mylan, and Depomed for documents and records from the last five years indicating what the companies knew about risk for abuse of opioids and their marketing
Drugs
Purdue Pharma is asking FDA to ensure that follow-on products citing its Butrans (buprenorphine) transdermal system for transdermal administration as the reference-listed drug are as safe and effective as Butrans. The company’s petition specifically asks the agency to: * require that applications referencing Butrans contain appropriate toxicology and
Drugs
Attorney Kurt Karst says that an apparent settlement between FDA and Ferring Pharmaceuticals over five-year new chemical entity (NCE) exclusivity for Ferring’s colonoscopy prep Prepopik (sodium picosulfate, magnesium oxide, and citric acid) for oral solution is likely to cause problems for the agency’s Office of Generic Drugs
Drugs
FDA associate commissioner for international programs Mary Lou Valdez says that regulators and drug companies in India recognize that a quality culture is imperative if the country is to increase productivity, reduce compliance risk, lessen rework, and minimize supply interruptions that result in lost revenue and increased risks to public
Drugs
FDA has approved a Regeneron Pharmaceuticals NDA for Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema. The drug is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable, an agency release says. Injected under the
Drugs
NDA Group says its fourth annual comparison of drug approvals in the U.S. and Europe shows a drop in U.S. approvals, but not in the European Union. For 2016, the report says, there were 74 new drug approvals granted in the U.S. and EU. Of those new
Drugs
A 3/14-3/22/16 FDA inspection at Opto-Pharm, Singapore, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 3/16 Warning Letter. Specific violations observed during the inspection included * failing to establish and follow appropriate written procedures designed to prevent
Drugs
Perrigo says the flexibility provided by FDA in a revised quality metrics draft guidance to allow reporting by site or by product “has the potential to create added confusion for key partners across the supply chain due to the potential for some partners to prefer site reporting and others to
Drugs
An FDA inspection at the Northwestern University School of Medicine between 6/17/16 and 7/11/16 found that Division of Immunotherapy chief Richard Burt violated regulations governing the proper conduct of clinical studies involving investigational new drugs. Specific violations included: * failing to fulfill the general responsibilities of sponsors
Drugs
The 3rd Circuit Court of Appeals has vacated a New Jersey federal court decision that failure-to-warn and other claims against Merck involving thigh bone fractures caused by its Fosamax (alendronate sodium) were preempted by federal law. The appeals court remanded the case to the lower court for further
Drugs
FDA has denied an Osmotica Pharmaceutical petition asking the agency to require that any ANDA seeking approval of venlafaxine HCl extended-release tablets 225 mg and referencing the company’s NDA-approved product demonstrate in vivo bioequivalence using the 225 mg strength. A 12/9/2016 citizen petition said the
Drugs
As Congress and president Trump pledge to address skyrocketing drug costs, a new report by consumer advocacy group Public Citizen calls into question industry arguments that pricing reflects the high cost of research and development to bring new therapies to market. The 20 largest pharmaceutical corporations “collectively profited more than
Drugs
FDA has denied a 10/2016 Sandoz citizen petition that asked FDA not to approve generic copies of GlaxoSmithKline’s asthma inhaler Advair Diskus 100/50 (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder) unless ANDA submissions contain data from a pharmacokinetic (PK) bioequivalence study that is stricter
Drugs
FDA has approved a Tesaro, Inc. NDA for Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely or partially shrunk in response to platinum-based chemotherapy. Zejula is a poly ADP-
Drugs
An Eagle Pharmaceuticals 505(b)(2) NDA for Ryanodex (dantrolene sodium) for treating exertional heat stroke (EHS) has been accepted for priority review. The agency has set a user fee review target date of 7/23. “Our innovative formulation of dantrolene sodium has unique properties that may allow Eagle’s
Drugs
Allergan says it will file an NDA in the second half of this year after announcing data from two Phase 3 trials of sarecycline for treating moderate to severe acne met their 12 week primary efficacy endpoints. Sarecycline is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-
Drugs
FDA has cleared a BioStable Science & Engineering 510(k) for the HAART 300 Aortic Annuloplasty device, designed for aortic valve repair. It is intended to re-size, reshape, and stabilize the aortic annulus to “restore valve competence and help prevent recurrent aortic regurgitation,” according to the company. “Valve repair
Drugs
FDA has granted Genentech a breakthrough therapy designation for Rituxan (rituximab) and its use for treating pemphigus vulgaris, a rare, serious and life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes. The company is currently enrolling patients in a Phase 3 study (PEMPHIX, NCT02383589), a
Drugs
Eli Lilly says it will invest $850 million in its U.S. operations in 2017 to expand its U.S. research laboratories, manufacturing sites, and general and administrative areas. “The investments are being driven by demand for Lilly products, as well as its robust pipeline of potential medicines in development
Drugs
FDA has approved a Shionogi Inc. and Purdue Pharma NDA for Symproic (naldemedine) 0.2 mg tablets, a once-daily oral peripherally-acting mu-opioid receptor antagonist for treating opioid-induced constipation in adult patients with chronic non-cancer pain. The companies say Symproic is currently a Schedule II controlled
Drugs
FDA has accepted for review a Symbiomix NDA for its lead investigational product candidate Solosec (secnidazole oral granules), an antibiotic designed to treat bacterial vaginosis (BV). The agency has granted a six-month priority-review designation with a user fee review target date of 9/17. The company described Solosec
Drugs
FDA has revised its Medication Guides list with one new guide and 21 updated documents. The new guide is for Orexigen’s Contrave (naltrexone HCl and bupropion HCl) ER. Updated guides are available for: GlaxoSmithKline’s Advair HFA (fluticasone propionate and salmeterol xinafoate), Atnahs’ Anaprox (naproxen sodium), Depomed’s Cambia