Drugs
Sage Therapeutics and Biogen say they will not seek an expanded use (major depressive disorder (MDD)) for postpartum depression (PPD) drug Zurzuvae (zuranolone). In 2023, FDA issued a complete response letter on an NDA seeking approval for zuranolone in the treatment of adults with MDD. “Sage and Biogen will not
Drugs
Rep. Abigail Spanberger (D-VA) is asking FDA and the Drug Enforcement Administration (DEA) to provide additional information on their work to end shortages of attention deficit hyperactivity disorder (ADHD) medications, including Adderall. A media statement says that while DEA has adjusted production quotas for certain ADHD medications and encouraged
Drugs
FDA has just posted the establishment inspection report issued following a 5/29-6/9/2023 inspection at the Boehringer Ingelheim drug manufacturing facility in Shanghai, China. The report says it covered the initial inspection of the facility and was limited to the manufacturing of a redacted drug substance and
Drugs
In advance of the 10/31 meeting of the FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss the Lexicon Pharmaceuticals resubmitted NDA for sotagliflozin (Zynquista), the agency released a briefing document with questions for the committee to consider. The document says Lexicon is proposing an indication for Zynquista
Drugs
FDA has accepted for review a PTC Therapeutics NDA resubmission for Translarna (ataluren) and its use in treating nonsense mutation Duchenne muscular dystrophy. In 2017, the agency issued a complete response letter on the original NDA, which called for effectiveness evidence from an additional adequate and well-controlled clinical trial.
Drugs
FDA has granted Prolong Pharmaceuticals a fast-track designation for PP-007 (PEGylated carboxyhemoglobin, bovine) and its use for treating acute ischemic stroke. The company says the drug has been shown to open collateral vessels, selectively deliver oxygen to hypoxic neurons, and reduce inflammation in stroke victims. PP-007 is
Drugs
FDA has accepted for review a Shanghai Henlius Biotech and Organon BLA for HLX14, an investigational biosimilar of Amgen’s Prolia/Xgeva (denosumab). The submission is based on data from head-to-head studies, including comparative quality analytical studies and two clinical studies, the companies say. In 2022, Henlius entered
Drugs
A 5/6-5/10 FDA inspection at the MedOffice Saglik Endustri Anonim Sirketi drug manufacturing facility in Torbah/Izmir, Turkey, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/23 Warning Letter says the specific violations were: * failure to have, for each batch
Drugs
FDA has released the form FDA-483 issued following a 3/15-3/25 inspection at a Novo Nordisk drug substance manufacturing site in Kalundborg Sjalland, Denmark. The eight inspection observations were: * the routine sample volume that is used to test for appropriate standards of quality and purity of the
Drugs
FDA has published a guidance, Emerging Scientific and Technical Information on Ritonavir, that sets an acceptable intake (AI) limit of 26.5 ng/day for a nitrosamine drug substance-related impurity known as NITMA (N-((2-isopropylthiazol-4-yl)methyl)-N-methylnitrous amide that may be present in some finished
Drugs
FDA has approved a Grifols BLA supplement for its plasma-protein based fibrin sealant Vistaseal for controlling surgical bleeding in pediatric patients. The product combines two plasma proteins — fibrinogen and thrombin — and is applied with Johnson & Johnson MedTech’s airless spray technology to rapidly form clots. J&J
Drugs
FDA has approved Protega Pharmaceuticals’ Roxybond (oxycodone hydrochloride), an abuse-deterrent, immediate-release (IR) 10 mg tablet for managing pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The company says Roxybond is the only abuse-deterrent IR 10 mg oxycodone formulation that is
Drugs
A Canadian Health Policy Institute (CHPI) study says the U.S. won’t be able to manage healthcare costs by importing prescription drugs from Canada. CHPI CEO Brett Skinner looked at 2023 Canadian and American sales volumes for the 27 prescription drugs listed for importation in proposals submitted by Colorado
Drugs
FDA has granted an accelerated approval to Novartis for its supplemental NDA for Scemblix (asciminib) for the drug’s expanded use in treating newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). Currently, Scemblix is approved for adult patients with Ph+ CML-
Drugs
FDA has notified Vivus that it has removed the requirement for a cardiovascular outcome trial for its weight-management medication Qsymia (phentermine and topiramate extended-release capsules). An agency letter said that positive topline data from a postmarketing study evaluating the effect of Qsymia on 24-hour ambulatory blood pressure
Drugs
Republican House Energy and Commerce Committee members are calling for the transparent release of clinical data from taxpayer-funded research in reaction to a New York Times article about an NIH-funded researcher and a study of puberty-blocking drugs that was withheld from publication because of the “charged American
Drugs
A bipartisan Congressional effort is being made to broaden FDA interpretations when deciding on priority review vouchers to increase treatments for sickle cell disease (SCD). In a 10/25 letter to FDA commissioner Robert Califf, senator Tim Scott (R-SC) and rep. Danny Davis (D-IL) have raised concerns about
Drugs
Drug compounding outfit FarmaKeio Outsourcing has filed a lawsuit in the Northern Texas District Court against FDA seeking a court order to permit the compounding of sodium thiosulfate, an active ingredient used to treat severe medical conditions including cyanide poisoning and calciphylaxis. The firm’s complaint challenges what it calls
Drugs
FDA has issued PharmaTher a complete response letter (CRL) on its ANDA for Ketarx (ketamine) and its use in anesthesia, sedation, pain, mental health, neurological, and medical countermeasures indications. “The deficiencies cited in the CRL are classified as minor,” the company says. The agency letter requested new and updated information
Drugs
FDA has approved an Iterum Therapeutics NDA for Orlynvah (sulopenem etzadroxil and probenecid) for treating uncomplicated urinary tract infections (uUTIs) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. Approval was based on data
Drugs
FDA has granted Kind Pharmaceutical an orphan drug designation for AND017 and its use in treating sickle cell disease (SCD). The company says the preclinical work supporting AND017's designation will be presented in a future scientific meeting and published in a scientific journal. Hydroxyurea and L-glutamine are
Drugs
Responding to an FDA request for information on biosimilar product development guidances, Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports the agency issuing cross-cutting guidances for a class of biosimilar products rather than product-specific guidances (PSGs). The PhRMA comment letter says the trade group is concerned