Drugs
FDA has released the FDA-483 inspection report from a 2/27-3/17 agency inspection at SterRx, a Plattsburgh, NY, outsourcing facility. The inspection observations were: * aseptic processing areas are deficient regarding the system for monitoring environmental conditions; * procedures designed to prevent microbiological contamination of drug products purporting to
Drugs
FDA has approved Novo Nordisk’s BLA for Rebinyn (nonacog beta pegol; N9-GP) for treating adults and children with hemophilia B. The company says Rebinyn is indicated for on-demand treatment and control of bleeding episodes and the perioperative management of bleeding around the time of surgery in adults
Drugs
FDA has accepted a Pfizer supplemental NDA for Sutent (sunitinib) seeking to expand its use to include adjuvant treatment in adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancer-containing kidney). The user fee review target date is 1/2018. The
Drugs
Lupin Pharmaceuticals has recalled one lot (# L600518, Exp 05/18) of Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol) 1 mg/0.02 mg chewable and ferrous fumarate 75 mg tablets due to a complaint about a packaging error. The company says the contraceptive blister pack, when rotated 180 degrees
Drugs
FDA has denied a Mallinckrodt petition relating to the company’s Inomax without commenting on whether it will do any or all of the actions the company requested. The response lists the company’s petition requests as: * require that all future inhaled nitric oxide drug products and delivery systems be
Drugs
An online RealClear Health column by research assistant Jordan Reimschisel calls on FDA to increase support for drug innovation as its primary goal. The column says the goal that policy makers like Congress should pursue is to “create an environment in which innovation and entrepreneurship can thrive with as few
Drugs
FDA has approved the expanded use of Novartis’ Zykadia (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test. Zykadia first received accelerated approval in 2014 for patients
Drugs
FDA has issued Sunovion Pharmaceuticals a Complete Response Letter on its NDA for SUN-101/eFlow (glycopyrrolate), indicated for treating chronic obstructive pulmonary disease. The agency letter does not require Sunovion to conduct any additional clinical studies for approval according to the company, which added that it will work with
Drugs
FDA says that AstraZeneca is recalling one specific lot of its Brilinta (ticagrelor) 90 mg tablets 8-count physician sample bottles following reports that a professional sample bottle containing eight tablets of Brilinta also contained AZ’s Zurampic (lesinurad) 200 mg tablets. The agency notice says that unintentional dosing with
Drugs
FDA has cleared a Masimo 510(k) for a pediatric indication for its O3 regional oximetry with an O3 pediatric sensor. “Regional oximetry, also referred to as tissue or cerebral oximetry, may help clinicians monitor cerebral oxygenation in situations in which peripheral pulse oximetry alone may not be fully indicative
Drugs
Amgen is suing FDA for not accepting its study reports and denying six months of pediatric exclusivity for its Sensipar (cinacalcet), a management treatment for patients suffering from hyperparathyroidism. An online Life Sciences Intellectual Property Review report says Amgen claims in its filing that FDA is required to accept a
Drugs
A 4/18-5/11/16 FDA inspection at the B. Braun Medical facility in Irvine, CA, found repeat violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/12 Warning Letter from the agency’s Los Angeles District Office. Specific violations cited in the
Drugs
Belcher Pharmaceuticals is asking FDA to amend its sulfite warning requirement for sulfite-containing injectable epinephrine used in emergency situations “to remove misleading information and acknowledge the current availability of approved epinephrine products that do not contain sulfite.” Belcher produces a sulfite-free epinephrine injection. The company’s 5/25
Drugs
Officials of FDA, the European Medicines Agency, and Japan’s Pharmaceuticals and Medical Devices Agency agreed at a 4/26-4/27 meeting that some requirements for clinical studies for antibacterial agents for specific types of infections such as urinary and intra-abdominal infections could be harmonized. A meeting summary
Drugs
The House Energy and Commerce Committee has asked for additional information from NIH to verify corrections and the resolution of clinical research compliance issues, including fungal contamination, uncovered during a 2015 FDA inspection at the Institute’s pharmaceutical development section (see earlier story). The unit eventually shut down its operations
Drugs
FDA commissioner Scott Gottlieb told a House FDA Appropriations Subcommittee hearing 5/25 that the Trump Administration’s January-ordered hiring freeze at FDA has been lifted and the agency is expediting the addition of new hires. “In getting the hiring freeze lifted so quickly, Dr. Gottlieb and his team
Drugs
FDA has completed three inspections this month at contract research organization BioPharma Services, and it did not issue any Form 483s. Concurrent inspections occurred at both research centers in Toronto, Canada, and Columbia, MO, according to the company, which added that an additional inspection was conducted at the Columbia facility
Drugs
FDA has sent a complete response letter to Sun Pharma for its NDA for Elepsia XR (levetiracetam) extended-release tablets 1,000 mg and 1,500 mg. A company disclosure letter to the National Stock Exchange of India says the FDA letter references the agency’s recent inspection at the
Drugs
An FDA Small Business and Industry Assistance podcast gives instructions for complying with the requirement to file master files and associated documents in the electronic Common Technical Document (eCTD) format. Deadline for using the format has been extended from 5/5/17 to 5/5/18 to give companies an
Drugs
Some 65 members of the House of Representatives from both parties are urging FDA to rescind its decision restricting state-licensed pharmacies from compounding prescription drugs for healthcare providers to use in their offices. The move is being led by Reps. Chris Stewart (R-UT) and Earl Carter (R-GA)
Drugs
The FDA Oncologic Drugs Advisory Committee has voted 10-3 to recommend that the overall risk/benefit profile of Emmaus Life Science’s Endari for treating sickle cell disease is favorable. The agency has a PDUFA target date of 7/7 to act on the company’s NDA. If approved,
Drugs
FDA has granted Abeona Therapeutics an Orphan Drug Designation for its EB-101 gene therapy program for patients with dystrophic epidermolysis bullosa, including recessive dystrophic epidermolysis bullosa (RDEB), which are life-threatening genetic skin disorders characterized by skin blisters and erosions that cover the body. In a Phase 1/2