Biologics
An FDA 4/3-4/28 inspection of RTI Surgical, Alachua, FL, found multiple violations in the firm’s continuing manufacture of a bone graft product consisting of a scaffold composed of human demineralized bone matrix and cortical cancellous chips or strips, copackaged with a redacted isolated bone marrow, cryopreserved
FDA Policy/General
Federal Register notice: FDA has classified the prostatic artery embolization device into Class 2 (special controls). The action was in response to a 2016 BioSphere Medical de novo classification request for the Embosphere Microspheres. The agency has codified the classification by adding 21 CFR 876.5550 and naming the generic
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Lupin Ltd. Mumbai, India (11/6): FDA inspected the firm’s Goa and Indore drug manufacturing facilities in April and May and documented significant GMP violations with finished pharmaceuticals.
Drugs
As expected, President Donald Trump has nominated former Eli Lilly executive Alex Azar as the next HHS secretary, replacing former Rep. Tom Price, who resigned after his extensive use of private and military jets at taxpayer expense was documented. Before joining Lilly, Azar was a deputy HHS secretary under former
Drugs
The president and owner of a Florida pharmacy has pleaded guilty for his role in a compounding pharmacy fraud scheme, which impacted private insurance companies, Medicare and TRICARE. Nicholas A. Borgesano Jr. (New Port Richey, FL), the president and owner of A to Z Pharmacy of New Port Richey, pleaded
Drugs
Theravance Biopharma and Mylan NV have submitted an NDA for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA) as a once-daily, nebulized bronchodilator for treating chronic obstructive pulmonary disease. The submission is supported by the companies’ Phase 3 program — two replicate pivotal Phase 3 efficacy studies and
Drugs
The American Hospital Association (AHA) has urged FDA to intervene and “expedite the resolution of the worsening shortages of small-volume parenteral solutions that are so fundamental to patient care in hospitals.” In an 11/10 letter to FDA commissioner Scott Gottlieb, AHA said the shortages of widely-used, critical
Devices
FDA has cleared a Clinical Genomics and Quest Diagnostics 510(k) for its InSure One, an at-home collection, fecal immunochemical test intended to detect blood in stool. The device detects human hemoglobin in fecal samples to aid in identifying lower gastrointestinal bleeding. It requires sample collection from one bowel
Drugs
FDA has approved an EMD Serono supplemental NDA for a redesigned version of Gonal-f RFF Redi-ject (follitropin alfa injection) pen injector, indicated for inducing ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure. The product
Drugs
FDA has approved an Allergan supplemental NDA for Vraylar (cariprazine) for the maintenance treatment of adults with schizophrenia. Vraylar was previously approved for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of Bipolar I disorder in adults. Without maintenance treatment, 60 to 71% of schizophrenia
FDA Policy/General
Comments Sought on Condom Labeling Info Collection Federal Register notice: FDA seeks comments on an information collection for “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms — 21 CFR 884.5300.” 11/09/2017 Upcoming Blood Products Advisory Committee Meeting Federal Register notice: FDA announces an 11/
Drugs
FDA has accepted for review a Sunovion Pharmaceuticals NDA for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor for treating attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults. The submission is based on data from multiple placebo-controlled safety and efficacy studies involving about 2,500
Biologics
FDA has approved a Dynavax Technologies BLA for Heplisav-B [hepatitis b vaccine, recombinant (adjuvanted)] for immunization against hepatitis B infection in adults 18 years of age and older. Approval was based on data from three Phase 3 non-inferiority trials of nearly 10,000 adults who received Heplisav-B.
Devices
FDA has cleared a Lensar 510(k) for its IntelliAxis-L, the company’s latest astigmatism management feature to guide toric intraocular lens (IOL) alignment in cataract surgery procedures. This feature for the femtosecond laser platform provides “intraoperative imaging to precisely and permanently identify the location of the steep corneal
Drugs
FDA has cleared a Neusoft Medical Systems 510(k) for its new 128-slice NeuViz Prime CT scanner. The device features “Spectral Imaging” capabilities to perform image acquisition and processing at multiple energy levels for computed tomography. Neusoft says the scanner also offers 0.259 second rotation speed for high
Drugs
FDA has approved a Heron Therapeutics NDA for Cinvanti (aprepitant) injectable emulsion, a P/neurokinin-1 receptor antagonist indicated in adults, in combination with other antiemetic agents, for preventing acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. The therapy is also
Devices
FDA says it is no longer adding new adverse event codes for Medical Device Reporting (MDR) in response to device manufacturer requests. As part of an adverse event harmonization effort with the International Medical Device Regulators Forum (IMDRF), FDA expects to transition to the new coding as new annexes from
Drugs
FDA has approved a Teligent ANDA for a generic copy of Promius Pharma’s Sernivo, indicated for treating mild-to-moderate plaque psoriasis in patients 18 years of age or older. Annual sales for betamethasone dipropionate are about $43 million, according to QuintilesIMS Health data.
Drugs
FDA is continuing to take Indian drug manufacturers to task over compliance with agency regulations. The latest sees FDA issuing a combined Warning Letter to India-based Lupin after two drug manufacturing facilities at Goa and Indore were inspected earlier this year and investigators documented significant GMP violations. At Goa,
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection for “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms — 21 CFR 884.5300.” The document provides recommended labeling intended to provide important information for condom users, including the extent of protection provided by condoms against
FDA Policy/General
Federal Register notice: FDA has announced an 11/30 to 12/1 Blood Products Advisory Committee advisory committee meeting. Panel members will meet in an open session to discuss bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion.
Drugs
Insys Therapeutics is petitioning FDA to not approve any ANDA referencing its Syndros (dronabinol) oral solution if the ANDA relies on an agency waiver of bioequivalence studies. The petition also asks FDA to require ANDA applicants for generic Syndros to include fed and fasted state bioequivalence studies. “Insys is concerned