Otsuka is voluntarily recalling certain lots of ABILIFY® (aripiprazole) Tablets due to cross-contamination from extremely small amounts of another active pharmaceutical ingredient previously manufactured on the same equipment. Based on sample testing performed, there is no material patient risk associated with the trace level of contamination found. The voluntary recall has been initiated by Otsuka out of an abundance of caution, with the knowledge of the U.S. Food and Drug Administration. This recall is limited to the United States.

Consumers who have a product that is being recalled and who have concerns, should consult with their healthcare provider or pharmacy. Adverse reactions or quality problems experienced with the use of this product should be reported.

Otsuka America Pharmaceutical, Inc. can be reached by phone at 1-833-468-7852 Monday – Friday, 9 a.m. – 5 p.m. Eastern Time or by email: global_intake@otsuka-us.com or ProductComplaints@otsuka-us.com. The FDA's MedWatch Adverse Event Reporting program can be reached either online or by phone. To complete and submit the report Online: www.fda.gov/medwatch/report.htm or call 1-800-332-1088.

Read more here: https://www.otsuka-us.com/news/otsuka-us-voluntary-recall

April 2024 01US24EBC0008

PRINCETON, NJ – [September 28, 2021] – The McQuade Center for Strategic Research and Development, LLC (MSRD), a member of the global Otsuka family of pharmaceutical companies, announces today the launch of Otsuka’s Digital Pioneer Initiative (ODPI). The ODPI was created to accelerate Otsuka’s digital health capabilities through active and strategic engagement with early-stage companies focused on improving mental health and well-being.  MSRD also announced a strategic investment in Mindful Mamas—a digital solution for maternal and family mental wellness.

Both initiatives were unveiled during DTx East, the annual summit focused on defining how digital therapeutics are going to integrate into healthcare. The ODPI will focus its investments on digital health technologies such as augmented and virtual reality, artificial intelligence driven health agents, digital biomarkers, social support platforms, and mobile apps that include both prescription and non-prescription digital therapeutics. 

“The launch of Otsuka’s Digital Pioneer Initiative is yet another important step in solidifying our continued commitment to ensuring the future success of digital therapeutics,” said Robert McQuade, Ph.D., president, McQuade Center for Strategic Research and Development, LLC, and chief strategic officer, Otsuka Pharmaceutical Development & Commercialization, Inc. “We believe that digital solutions like the Mindful Mamas app will help shape the future of mental healthcare.”

Nurturing the mental well-being of moms

Nearly 70 percent of moms have experienced adverse health effects due to worry and stress related to the pandemic,[1] proving that their mental well-being needs to be a priority.  

Through mindfulness and meditation, the Mindful Mamas app offers support for uncertainty and stress by guiding mothers to cultivate equanimity, manage emotions, improve relationships, grow happiness, and sleep better. Since its inception in March 2020, the Mindful Mamas app has surpassed 125,000 downloads in over 50 countries through primarily organic efforts with the average active user accessing the app 2 times per day. Recent feedback from those who have used the app indicates that more than 80 percent of mothers reported feeling better or much better after completing a practice in the app.

“At Otsuka, we envision a future that leverages the broad capabilities of emerging technology to advance health and wellness,” said Joe Powers, Ph.D., vice president, chief digital business officer, Otsuka America Pharmaceutical, Inc. “The Mindful Mamas app is an excellent example of how digital solutions can provide ways to manage mental health challenges in real time.”

Mindful Mamas has plans to extend beyond mindfulness and meditation as they seek to diversify their content, offerings, and community on the app. Currently, members of Mindful Mamas have access to five main features that provide personalized content for unique motherhood experiences:

  • Guided Meditations centered around the joys and challenges of life and motherhood.
  • Mini Pauses of mindfulness that mothers can practice anywhere, in only a few moments, even with their kids around.
  • Breathing techniques to help with energy, relaxation, and balance.
  • Mantras consisting of empowering phrases to help mothers shift into a happier, more aligned mindset.
  • Get centered tools for immediate relief to leave chaos and return back to center.

“Mindful Mamas started with recognizing my own needs and where gaps existed—I saw a better way,” said Terra LaRock, founder and CEO, Mindful Mamas. “As a mental health practitioner, I was blindsided by my struggle with postpartum depression and obsessive-compulsive disorder with my first child. Mindful Mamas is on a mission to equip moms-to-be and mothers of young children with the mental and emotional tools they need to thrive in motherhood and in life. I feel gratified that Otsuka shares a similar vision and I’m excited about the future.”

 

About Otsuka

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 1,700 employees in the U.S. develop and commercialize medicines in the areas of mental health, nephrology, and cardiology, using cutting-edge technology to address unmet healthcare needs. 

OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 47,000 people worldwide and had consolidated sales of approximately USD 13.3 billion in 2020.

All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on LinkedIn and Twitter at @OtsukaUS. Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at www.otsuka.co.jp/en/.

 

Contacts for media

Otsuka In U.S.                                                                                            

Jill Roman
Corporate Communications
Otsuka America Pharmaceutical, Inc.
jill.roman@otsuka-us.com
+1 215 595 8424                                                      

[1] https://www.kff.org/policy-watch/its-back-to-school-amid-covid-19-and-mothers-especially-are-feeling-the-strain/