Drugs
FDA has granted tentative approval to Upsher-Smith Laboratories for its supplemental NDA for Qudexy XR (topiramate) extended-release capsules for use as prophylaxis of migraine headache in adults. Company chief scientific officer William Pullman says that there are no extended-release topiramate formulations approved for migraine prophylaxis in the
Drugs
Salix Pharmaceuticals has agreed to pay $54 million to the U.S. government to settle a civil fraud lawsuit that alleged the company had violated the federal Anti-Kickback Statute and False Claims Act by using its “speaker programs” as a mechanism to pay kickbacks to doctors to induce them
Drugs
Members of FDA’s Anesthetics and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Committee voted 9-6 on 6/8 to support the safety and efficacy of Pfizer’s NDA for Troxyca ER (oxycodone HCl and naltrexone HCl extended-release capsules). The company is seeking
Drugs
FDA has issued two interim guidance on the use of bulk drug substances in compounding under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act. An agency statement (includes links to guidances and other documents) says the guidances explain FDA’s policy about the conditions under which
Drugs
As part of its involvement in Interpol’s 5/31-6/7 Ninth Annual Internet Week of Action (Operation Pangea IX), FDA took action against 4,402 Web sites, asking their domain registrars to suspend them for illegally selling potentially dangerous unapproved prescription drugs to U.S. consumers. The agency
Drugs
FDA has approved a new formulation of ThromboGenics’ Jetrea (ocriplasmin) — an already-diluted formulation that eliminates the current preparatory dilution steps prior to injection. Jetrea is approved in the U.S. for treating symptomatic vitreomacular adhesion (VMA), an age-related progressive, sight-threatening condition that may lead to visual distortion,
Drugs
KemPharm has filed an NDA amendment for Apadaz (benzhydrocodone hydrochloride and acetaminophen), an investigational abuse-deterrent product candidate for the short-term management of acute pain. The amendment is focused on providing the agency additional information KemPharm seeks to include in the FDA's current NDA review, the company
Drugs
FDA has accepted for review an Ironwood Pharmaceuticals and Allergan supplemental NDA for a 72 mcg dose of linaclotide for use in treating adults with chronic idiopathic constipation (CIC). The submission is based on efficacy and safety data from a double-blind, placebo-controlled Phase 3 clinical trial involving 1,
Drugs
Sen. Dan Coats (R-IN) has introduced S. 2998, the Ensuring Patient Access to Critical Breakthrough Products Act, to “establish a program to accelerate transitional coverage and payment for new technologies that offer breakthroughs for serious illnesses affecting Medicare beneficiaries.” In a statement, the senator says that “researchers and entrepreneurs
Drugs
A joint meeting by FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee has voted 14 to 3 to support approval of Teva’s Vantrela ER (hydrocodone bitartrate extended-release tablets) for managing pain severe enough to require long-term opioid treatment
Drugs
The Justice Department says that Genentech and OSI Pharmaceuticals, who are co-promoting the cancer drug Tarceva, have agreed to pay $67 million to resolve a whistleblower’s False Claims Act allegations that they made misleading statements about the drug’s effectiveness. A department statement says the allegations claimed that
Drugs
A Northern California federal judge has tossed out a Merck $200 million jury verdict against Gilead Sciences after finding misconduct by the company and one of its expert witnesses. The case, Gilead Sciences v. Merck & Co., involved assertions by Merck that two of its patents cover sofosbuvir, and that
Drugs
FDA has granted Remedy Pharmaceuticals a fast track designation for its investigational drug Cirara and its use in treating large hemispheric infarctions (LHI). The company is planning a Phase 3 trial called CHARM (Cirara in large Hemispheric infarction Analyzing modified Rankin & Mortality) in patients with LHI, a disease associated
Drugs
Sarepta Therapeutics and its eteplirsen for treating Duchenne muscular dystrophy received a shot in the arm 6/6 when, in an apparent compromise with FDA, the company agreed to an agency request that it provide dystrophin data, as measured by western blot, from biopsies already obtained from an ongoing confirmatory
Drugs
With the number of shipments of FDA-regulated products into the U.S. more than doubling from 15 million to more than 34 million in the past decade, the agency is implementing initiatives to keep pace, according to deputy commissioner for global regulatory operations and policy Howard Sklamberg. Writing in
Drugs
A 5/25-27/15 FDA inspection at Ko Da Pharmaceutical Co., Taoyuan City, Taiwan, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/27 Warning Letter. Specific violations noted include: * failure of the firm’s quality unit to approve or reject
Drugs
An FDA Office of Criminal Investigations case has led to a guilty verdict against Chenhsin Chan, also known as Paul Chan, in connection with his online marketing and sale of dietary supplements containing ephedrine in violation of a federal ban. Chan was found guilty in the Northern District of Georgia
Drugs
AstraZeneca is petitioning FDA to not approve any ANDA or 505(b)(2) NDA referencing its Crestor (rosuvastatin calcium) until expiration of the orphan drug exclusivity for using the drug to treat pediatric patients ages 7 to 17 with homozygous familial hypercholesterolemia (HoFH) The petition says that pediatric HoFH is
Drugs
A letter from 28 organizations, including Friends of Cancer Research, to FDA commissioner Robert Califf urges the agency to create an FDA Oncology Center of Excellence, providing detailed recommendations as to how this program could be implemented. The proposal asks the agency to “refocus resources” based on specific diseases to
Drugs
Commenting on the 5/3-5/4 joint meeting of FDA’s Drug Safety and Risk Management Advisory Committee and Analgesic Drug Products Advisory Committee, which discussed possible changes to REMS (Risk Evaluation and Mitigation Strategies) for extended release/long acting (ER/LA) opioid analgesics, the American Pharmacists’ Association said
Drugs
FDA has issued a drug safety alert to warn that taking higher than recommended doses of the common over-the-counter and prescription diarrhea medicine loperamide (Imodium) can cause serious heart problems that can lead to death. “The risk of these serious heart problems, including abnormal heart rhythms, may also
Drugs
FDA has issued Adamis Pharmaceuticals a second Complete Response Letter (CRL) on an NDA for epinephrine injection USP pre-filled single dose syringe product for the emergency treatment of acute anaphylaxis. The NDA was resubmitted earlier this year to address issues raised by a CRL issued 3/2015. That letter