FDA OKs Duvelisib for Some Lymphomas – APhA submits compounding comments to FDA.

6Alabama Defense Lawyer, Board of Pharmacy, Pharmacy Defense Attorney, KLF

FDA OKs Duvelisib for Some Lymphomas – APhA submits compounding comments to FDA. – (866) 348-2889.

The FDA has granted regular approval to duvelisib (COPIKTRA, Verastem) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least 2 prior therapies. The drug also received accelerated approval for adult patients with relapsed or refractory follicular lymphoma (FL) after at least 2 prior systemic therapies.

The recommended duvelisib dose is 25 mg orally twice daily, taken continuously in 28-day treatment cycles.

The CLL and SLL indication is based on a randomized, multicenter, open-label trial (NCT02004522) comparing duvelisib to ofatumumab in patients with relapsed or refractory CLL or SLL. The trial randomized patients (1:1) to either duvelisib (25 mg orally twice daily) or ofatumumab. Ofatumumab was administered intravenously at an initial dose of 300 mg, followed 1 week later by 2000 mg once weekly for 7 doses, and then 2000 mg once every 4 weeks for 4 additional doses.

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harmacy Owner Facing Federal Charges for Fraudulent Reimbursement Claims – Drug for nerve pain boosts high for opioid abusers.

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Pharmacy Owner Facing Federal Charges for Fraudulent Reimbursement Claims – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

A pharmacy owner facing an indictment charging her with submitting millions of dollars in fraudulent claims to Medicare and Medicaid is expected to be arraigned today in federal court in Brooklyn, New York, according to the United States Department of Justice (DOJ).

Aleah Mohammed, aka “Aleah Haniff,” 33, of Queens, New York, was the owner and operator of 4 pharmacies: Superdrugs Inc., Superdrugs I Inc., Superdrugs II Inc. and S&A Superdrugs II Inc. Her pharmacies received approximately $7.9 million in fraudulent reimbursements from Medicare and Medicaid, from approximaely May 2015 through June 2018, when Mohammed was arrested on the complaint, DOJ officials said in a press release.

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Case Report: Advising a Patient on Shingles Vaccine – APhA submits compounding comments to FDA.

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Case Report: Advising a Patient on Shingles Vaccine – APhA submits compounding comments to FDA. – (866) 348-2889.

LL is a 66-year-old woman who is looking for papain tablets. She said that she read that the tablets can help with herpes zoster. Some of LL’s friends had shingles, and a few of them tried the tablets and found them beneficial. She has never had shingles but wants to take the tablets preventively. LL’s immunization card shows that she has the influenza vaccine yearly and that she had the pneumococcal conjugate vaccine 13 at age 65, the pneumococcal polysaccharide vaccine 23 at age 66, and the tetanus, diphtheria, and pertussis vaccine at age 63. All her childhood vaccinations are up-to-date. LL’s medical history includes hypertension, but she manages it through diet. Upon questioning, she says that she has not received the herpes zoster vaccine. LL was confused about which to get, so she avoided both. What recommendations do you have?

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Generic Dalfampridine Tablet Marketed for Patients With MS – Drug for nerve pain boosts high for opioid abusers.

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Generic Dalfampridine Tablet Marketed for Patients With MS – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Mylan has launched its 10 mg Dalfampridine Extended-Release Tablets, an authorized generic version of Acorda’s Ampyra (dalfampridine).1 Dalfampridine, which is being marketed to to treat adult patients with multiple sclerosis (MS), is indicated to improve patients’ ability to walk and increase speed.1-2

In a prepared statement, Mylan CEO Heather Bresch said the availability of the generic product is reflective of the company’s commitment to providing medication access to patients with MS. “Mylan offers 100 products in the area of CNS alone, including 20 of the top CNS products dispensed in the US,” she noted.1

The most common adverse effects associated with the use of Ampyra are urinary tract infection, insomnia, dizziness, headache, nausea, weakness, and back pain.2 Patients who use the drug are also at an increased risk for seizures, according to the FDA.3

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Rite Aid Officials: Grief Counselors Will Be Available As Long As Needed – APhA submits compounding comments to FDA.

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Rite Aid Officials: Grief Counselors Will Be Available As Long As Needed – APhA submits compounding comments to FDA. – (866) 348-2889.

Officials with Rite Aid noted that grief counselors are being made available following a shooting this morning at the Liberty support facility, which is part of Rite Aid’s Perryman Distribution Center in Aberdeen, Md.

“Local authorities have confirmed that there are multiple fatalities and casualties,” Rite Aid officials wrote on their Facebook page. CNN, citing unnamed sources, reported that a woman killed 3 people at the center before shooting herself.

“We are continuing to work closely with authorities as they conduct their investigation. The facility has been closed, and we are assessing when it will be reopened,” the social media post from Rite Aid explained. The post continued that grief counselors will be made available to associates and “will remain available as long as they are needed. Our thoughts and prayers go out to all those involved in this tragic incident, as well as their loved ones.”

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Oral Semaglutide Demonstrates Benefits for Patients With Type 2 Diabetes – Drug for nerve pain boosts high for opioid abusers.

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Oral Semaglutide Demonstrates Benefits for Patients With Type 2 Diabetes – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

A global phase 3a trial successfully demonstrated greater reductions in HbA1c and body weight with a oral semaglutide drug treatment than with dulaglutide, as well as a a comparable number of adverse events in 458 Japanese adults with type 2 diabetes between these medications. The 57-week randomized PIONEER 10 trial compared 3mg, 7mg, and 14 mg oral semaglutide versus 0.75 mg of once-weekly subcutaneous dulaglutide, a dosage approved by Japan’s Pharmaceutical and Medical Devices Agency.1

During the PIONEER 10 trial, which tested the safety, tolerability and efficacy of oral semaglutide, both drugs were used in combination with 1 oral antidiabetic drug, according to Novo Nordisk, whose officials announced the study results Thursday, in a prepared statement. Oral semaglutide is an investigational GLP-1 analogue taken once daily as a tablet. The FDA approved a pre-filled pen version of Novo Nordisk’s semaglutide in late 2017.2

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Good Stewardship Principles Aim to Strengthen 340B Program – APhA submits compounding comments to FDA.

2501_GraphicImage_061915-piAlabama Defense Lawyer, Board of Pharmacy, Pharmacy Defense Attorney, KLF

Good Stewardship Principles Aim to Strengthen 340B Program – APhA submits compounding comments to FDA. – (866) 348-2889.

The American Hospital Association (AHA) and individual hospitals have initiated new principles for ensuring good stewardship of the 340B drug program. The goals are to ensure that the 340B program increases transparency, and assists participating hospitals in better communicating the program’s value for vulnerable patients and communities.1

“The 340B stewardship principles will help hospitals better tell their story of how this crucial program is delivering a variety of important benefits to patients and communities,” said Rick Pollack, president and CEO of the AHA, in a prepared statement.1 “In an era of skyrocketing drug prices, 340B has been critical in helping hospitals expand access to comprehensive health services, including lifesaving prescription drugs.”

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New Treatment for Plaque Psoriasis Approved in Europe – Drug for nerve pain boosts high for opioid abusers.

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New Treatment for Plaque Psoriasis Approved in Europe – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Almirall has received European Commission approval for its plaque psoriasis treatment tildrakizumab (Ilumetri), Sun Pharma announced in a press release.

Tildrakizumab, a humanized high-affinity anti-IL-23p19 monoclonal antibody, is indicated for the treatment of adults with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy. Sun Pharma out-licensed tildrakizumab to Almirall for the development and commercialization of the product for psoriasis in Europe.

The drug’s European approval is based on data from the reSURFACE 1 and 3 phase 3 clinical trials, which included 1800 patients from more than 200 clinical sites worldwide and evaluated tildrakizumab’s safety and efficacy.

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FDA OKs Generic Vaginal Inserts for Treatment of Menopause Symptoms – APhA submits compounding comments to FDA.

1Alabama Defense Lawyer, Board of Pharmacy, Pharmacy Defense Attorney, KLF

FDA OKs Generic Vaginal Inserts for Treatment of Menopause Symptoms – APhA submits compounding comments to FDA. – (866) 348-2889.

Generic estradiol vaginal inserts have have received final FDA approval to relieve the symptoms of menopause in women. Glenmark’s newly approved Estradiol Vaginal Inserts USP are equivalent to Novo Nordisk’s VAGIFEM.1

Menopause, the time when a woman’s menstrual cycle ends and she is no longer fertile, results in a reduction in both estrogen and progesterone production. Low levels of these 2 hormones can lead to symptoms such as hot flashes, sleep problems, painful sexual intercourse, mood changes, or depression and anxiety.2 Hormone therapy, such as estradiol vaginal inserts, can help replenish estrogen levels and reduce these symptoms, according to the US Department of Health and Human Services’ (HHS) Office on Women’s Health.

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FDA Approves Drug Treatment to Prevent Migraines – Drug for nerve pain boosts high for opioid abusers.

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FDA Approves Drug Treatment to Prevent Migraines – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Officials with the FDA have approved fremanezumab-vfrm (Ajovy, Teva) for the preventive treatment of migraine in adults.1

Fremanezumab-vfrm is the second FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks. The first in this class, erenumab-aooe (Aimovig) was approved in May.1

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