PHARMACY

Alembic Pharmaceuticals debuts in U.S. with Namenda generic

BY David Salazar

GUJARAT, India — Alembic Pharmaceuticals has kicked off its operations in the United States with the launch of its memantine hydrochloride tablets, a generic of Namenda. The drug, which is indicated to treat Alzheimer’s diseases and dementia, will be available in 5- and 10-mg dosage strengths.

“We are very excited about the launch of Memantine tablets and the opportunity to provide patients an affordable therapeutic option” Craig Salmon, Alembic’s president of U.S. operations said.  “This is an important step for Alembic and the first of many new products to be launched into the U.S. market in the immediate future.”   

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PHARMACY

FDA approves Tris Pharma’s Dyanavel XR

BY David Salazar

MONMOUTH JUNCTION, N.J. — Tris Pharma on Tuesday announced that it had received approval from the Food and Drug Administration for its Dyanavel XR (amphetamine) extended-release oral suspension. Dyanavel is indicated as a once-daily treatment for attention deficit/hyperactivity disorder in children ages 6 and older.

“Dyanavel XR is the first and only once-daily, extended-release amphetamine oral suspension for the treatment of ADHD,” Tris’ chief medical officer Dr. Sally Berry said. “Amphetamines are well-established as effective treatment for ADHD.  Dyanavel  XR offers physicians a new pediatric-friendly dosing option that couples fast onset with a long duration of effect suitable for school-aged children.”

The drug is expected to be available in 2016, the company said. 

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New drug safety alliance launches to tout REMS benefits

BY David Salazar

WASHINGTON — A new coalition of 20 healthcare organizations has come together to form the Patients Alliance for Drug Safety Protections, whose goal is to tout the public health benefits of Risk Evaluation and Management Strategies (REMS). The PADSP has also launched a website, DrugProtections.org, that explains the REMS program to patients and lists medication that are currently marketed with a REMS.

Spearheaded by the Society for Women’s Health Research (SWHR), the organization said that it formed at a time when patients, policymakers and stakeholders face a knowledge gap about the REMS system, which can ensure the safety of drugs meant to treat such illnesses as cancer or multiple sclerosis.

“Several conditions require access to treatments that may have significant risk factors. Without the protections created by REMS programs, these drugs would not be allowed on the market and patients would suffer tremendously,” SWHR president and CEO Phyllis Greenberger said. “This alliance was established in coordination with knowledgeable and experienced advocates for patients and physicians who are worried about recent efforts to weaken REMS protections, putting public health and patient access at risk.”

The members of the alliance are: the Alliance for the Adoption of Innovations in Medicine, the American Association of Kidney Patients, the American Cancer Society Cancer Action Network, the American College of Obstetricians and Gynecologists, the Association of Reproductive Health Professionals, C-Change, the Center for Lawful Access and Abuse Deterrence, the Consortium of MS Centers, the Cutaneous Lymphoma Foundation, HealthyWomen, the International Myeloma Foundation, the Leukemia & Lymphoma Society, March of Dimes, the MDS Foundation, the Multiple Myeloma Research Foundation, the National Association of Nurse Practitioners in Women's Health, the Organization of Teratology Information Specialists, Patients Rising and the Teratology Society.

“The American College of Obstetricians and Gynecologists (ACOG) is a proud member of the coalition to advance the importance of REMS as a tool to improve public health,” Dr. Mark S. DeFrancesco, president of ACOG, said. “As the nation's leading group of physicians providing health care for women, we recognize the importance of drug safety measures, particularly to prevent severe complications and birth defects that can result from inappropriate medicine distribution and use. We encourage healthcare organizations to work collaboratively to design and conduct drug studies in order to ensure that people with serious diseases have access to appropriate treatments.”

The alliance will also work to highlight the importance of REMS with Elements to Assure Safe use (ETASU) programs, and will support advocacy efforts that push to preserve patient access and strengthen REMS programs while also working to make sure that manufacturers meet safety requirements for drug designs and studies.

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