FDA Conditionally Approves First Oral Tablet to Treat Lymphoma in Dogs

Today, the U.S. Food and Drug Administration conditionally approved Laverdia-CA1 (verdinexor tablets) to treat dogs with lymphoma, a type of cancer of the lymph nodes and lymphatic system. Laverdia-CA1 works to prevent certain proteins from leaving the nucleus of cancer cells, thereby allowing these proteins to control the growth and prevent the spread of cancerous cells in dogs.

Laverdia-CA1 is the first conditionally approved oral treatment for dogs with lymphoma. Because Laverdia-CA1 is orally administered, owners of dogs with a diagnosis of lymphoma, following a veterinarian prescription and safety directions detailed in a client information sheet, can administer this treatment at home. Laverdia-CA1 is given orally twice per week, with at least 72 hours between doses. Laverdia-CA1 is the second treatment for lymphoma in dogs that the FDA has...https://www.fda.gov/news-events/press-announcements/fda-conditionally-approves-first-oral-tablet-treat-lymphoma-dogs?utm_medium=email&utm_source=govdelivery

 Wisconsin Pharmacist Accused of Destroying COVID-19 Vaccines Is Allegedly a 'Conspiracy Theorist'

In divorce filings, Steven Brandenburg's wife alleges he was stockpiling bulk food and guns

Read in People: https://apple.news/AS94WPA70Sfe0-BEWnsJeqA

 

01/05/2021	12/18/2020	Reddy Naturals	Division of Human and Animal Food Operations East III	New Drug/Misbranded
01/05/2021	01/04/2021	Coco's Holistic Specialties & Apothecary	Center for Drug Evaluation and Research | CDER	Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

 

• Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

 

Proposed Rules Title 22 - Texas Secretary of State

www.sos.state.tx.us › texreg › archive › October22020

4 days ago — (ii) If the extent of the loss of controlled substances or dangerous drugs is not able to be determined, ... (x) compounding non-sterile prescription drug orders; and.

 

Empire Pharmacy Owner Admitted Participation in Multi ...

healthcarefraudgroup.com › news › empire-pharmacy-...

5 days ago — To lure medical physicians into using Empire to fill such medications, Eduard Shtindler ... the physician directed patients to obtain medications from Empire pharmacy, ... In 8.8 Million USD Compounded Medication Prescription Plot Read More.

Northern District of Oklahoma United States Attorney's Office Collects $6.4 Million in Civil and Criminal Actions in Fiscal Year 2020

 The civil False Claims Act is an important tool used to protect the integrity of taxpayer-funded health care programs and allows the government to address losses it sustains by providing for civil monetary penalties.

• In FY 2020, the U.S. Attorney’s Office civil division assessed such a penalty against a Louisiana physician assistant for accepting illegal pharmacy kickback payments in return for recommending and prescribing compounded drugs from OK Compounding. He entered into a settlement agreement with the United States, agreeing to pay $620, 508.36.
• In another settlement agreement, a Texas doctor agreed to pay the United States $300,000 to resolve False Claims Act allegations that he accepted illegal kickback payments from OK Compounding. The settlement agreements resolved allegations against both men.
• Quoted from https://www.justice.gov/usao-ndok/pr/northern-district-oklahoma-collects-64-million-civil-and-criminal-actions-fiscal-year

 

Kentucky pharmacy owner pleads guilty to unlawful ...

www.newsbreak.com › Kentucky State › Nicholasville

6 days ago — A compounding pharmacy in Nicholasville, Ky., and its owner admitted in federal court to the unlawful distribution of compounded prescription drugs, the U.S. .

 

2021 compounding pharmacy self- inspection form - State of ...

www.oregon.gov › pharmacy › Documents › Compou...

PDF

7 days ago — COMPOUNDING PHARMACY. SELF- INSPECTION FORM. ATTENTION: PHARMACIST-IN-CHARGE (PIC). Oregon law holds the pharmacist-in-charge (PIC) ..

 

FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine

The following is attributed to Patrizia Cavazzoni, M.D., acting director of the Center for Drug Evaluation and Research

Advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug development, including the development of drugs for the treatment of rare diseases. These advances have contributed to an increase in development and approval of drugs for the treatment of rare diseases in recent years. In fact, in the past eight years, the U.S. Food and Drug Administration has approved more than twice as many drugs for rare diseases, often referred to as orphan drugs, as in the previous eight years.

For genetic diseases, recent approaches to testing and molecular diagnosis have allowed us to pinpoint, in some cases, the exact cause of a patient’s disease. For a patient with a very rare genetic disease...