Drugs
FDA has approved changes to Abbott’s Kaletra (lopinavir/ritonavir) tablet and oral solution labels, for treating adult patients with HIV who have previously taken antiretroviral therapy. These changes include updates to the Dosage And Administration section with information about use of the oral solution with a feeding tube. “Because
Drugs
FDA has accepted for review a Sandoz ANDA for fluticasone propionate/salmeterol in combination, a generic version of GlaxoSmithKline’s Advair Diskus. The product is indicated for treating asthma in patients aged four years and older, in addition to providing maintenance treatment of airflow obstruction and reducing exacerbations in patients
Drugs
Delegates to the American Medical Association (AMA) annual meeting approved a policy to increase transparency of drug costs by calling on manufacturers to list the suggested retail price of drugs in direct-to-consumer ads. “The AMA will urge the appropriate federal agencies to include that requirement,” an association news
Drugs
FDA commissioner Scott Gottlieb says it is incumbent upon the agency to have policies in place to promote safe and effective innovation to benefit consumers and to adopt regulatory approaches to enable efficient development of the technologies. To that end, he writes in an FDA Voice blog post, FDA will
Drugs
Public Citizen says that the Stop Price Gouging Act (number and text not yet available) introduced by Sens. Sherrod Brown (D-OH) and Kirsten Gillibrand (D-NY) would limit annual prescription drug price spikes or cumulative price hikes over five years. “This bill is the cure for the epidemic of
Drugs
FDA has approved Adamis Pharmaceuticals’ Symjepi (epinephrine) 0.3 mg pre-filled single dose syringe for the emergency treatment of allergic reactions (Type I) including anaphylaxis. Symjepi comes in two single dose units for treating acute anaphylactic reactions to insect stings or bites, allergic reaction to foods (such as nuts)
Drugs
FDA has released a new version of Form FDA 3331a, available on its Field Alert Reports Web page, that serves as an automated form for field alert report (FAR) submissions. FDA just completed a pilot program on such electronic submissions, which allow simultaneous reporting to FDA’s Office of Regulatory
Drugs
Teva Pharmaceuticals has recalled one lot of paliperidone extended-release tablets, 3mg, 90 count bottles (lot 1160682A), which was distributed under the Actavis Pharma Inc. label, due to failing test results for dissolution. Teva says it cannot at this time exclude the potential for additional tablets to be below specification
Drugs
FDA has published fictional case studies as part of an educational series on qualifying biomarkers for use in drug development. The agency says the studies “are intended to help patients, patient advocacy groups, health professionals, small businesses, and pharmaceutical and clinical innovators learn more about the role of biomarkers and
Drugs
The Government Accountability Office (GAO) says FDA and the Federal Trade Commission (FTC) should give consumers additional guidance to clarify the agencies’ differing roles in their shared oversight of memory supplement and other dietary supplement marketing on the Internet. A GAO report examines (1) how memory supplements are marketed and
Drugs
FDA has issued a guidance, E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs—Questions and Answers (R3), to facilitate implementing the International Conference on Harmonization (ICH) 2005 E14 guidance. The document says the questions and answers arise from experiences implementing the guidance in
Drugs
Takeda’s Millennium Pharmaceuticals unit is again raising issues related to ANDAs or 505(b)(2) applications for its Velcade (bortezomib) for injection, described as a first-in-class proteasome inhibitor approved to treat multiple myeloma and mantle cell lymphoma. In a 6/8 citizen petition, Millennium references its 8/
Drugs
Phillips Company is recalling all lots of its Tetrastem, Diabecline, Tetracycline-ABC, VenomX, Acneed, StaphWash, StringMed, NoPain, and LidoMed topical products to the retail level. In a statement published by FDA, the company says the recall follows an FDA inspection that found significant manufacturing practices calling into question the products’
Drugs
BioMedEcon is asking FDA to require labeling changes for manufacturers of dopamine agonists used to treat restless leg syndrome including risks of serious mental disorder reactions. The petition specifically cites Mirapex (pramipexole), Requip (ropinirole HCl), and Neupro (rotigotine). The agency is asked to: * require addition of a Boxed Warning to
Drugs
Achelios Therapeutics says it is planning a 505(b)(2) NDA for Topofen (ketoprofen), a topical formulation of the non-steroidal anti-inflammatory drug (NSAID) for treating acute and chronic migraine. The company says it recently completed a Phase 2a study demonstrating that topical application to facial areas innervated by
Drugs
FDA has granted Omeros Corp. a breakthrough therapy designation for OMS721 for treating immunoglobulin A (IgA) nephropathy. The monoclonal antibody is designed to target mannan-binding lectin-associated serine protease-2 (MASP-2), the “effector enzyme of the lectin pathway of the complement system,” according to the company. The designation
Drugs
FDA commissioner Scott Gottlieb says that as part of his initiative to identify more steps his agency can take to address opioid addiction, FDA will hold a 7/10-11 public meeting focusing on the question of whether the agency has the right information to determine whether opioid medications with
Drugs
Based on a data monitoring committee recommendation, Merck has paused new enrollment on KEYNOTE-183 and KEYNOTE-185, two studies exploring Keytruda (pembrolizumab) treatment in combination with other therapies in multiple myeloma. “The pause is to allow for additional information to be collected to better understand more reports of death
Drugs
FDA says it has approved five-year new chemical entity exclusivity for Pfizer’s Duavee (conjugated estrogens; bazefoxifene acetate), rendering moot a company 9/30/16 petition requesting the action in light of a DC federal court decision in Ferring Pharmaceuticals v. Burwell. The agency response says that at the
Drugs
FDA says it has entered into a long-term partnership with CancerLinQ, the American Society of Clinical Oncology’s big data initiative, to use cancer patient information and big data analytics to examine the real-world use of emerging and newly-approved cancer therapies. A statement issued by CancerLinQ says
Drugs
Stakeholders are praising FDA for proposing to create an Office of Patient Affairs (OPA). For example, the Biotechnology Innovation Organization (BIO) says it “applauds the agency for its continued commitment to advancing the science of integrating patient perspectives into drug development and regulatory review processes. We also support FDA’s
Drugs
Bristol-Myers Squibb has recalled one lot (#HN0063) of its blood thinner Eliquis (apixaban) 5 mg tablets after a customer complaint said a bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets. “Patients who are prescribed Eliquis 5 mg for an irregular heartbeat (atrial