Le Lézard
Classified in: Health, Science and technology
Subject: FDA

InvaGen (a Cipla Subsidiary) Receives Final Approval for Generic Version of Pfizer's Lyrica® (Pregabalin Capsules, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg)


NEW YORK and MUMBAI, India, July 22, 2019 /PRNewswire/ -- InvaGen Pharmaceuticals, Inc. ("InvaGen"), a wholly-owned subsidiary of the leading global pharmaceutical company Cipla Limited (BSE: 500087; NSE: CIPLA EQ; hereafter referred to as "Cipla") announced the receipt of final approval for its Abbreviated New Drug Application (ANDA) for Pregabalin Capsules, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg from the United States Food and Drug Administration (US FDA).

Cipla_Logo

InvaGen's Pregabalin Capsules, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg is AB-rated generic therapeutic equivalent version of Pfizer's Lyrica®. Pregabalin capsules are indicated for:

According to IQVIA (IMS Health), Lyrica® had US sales of approximately $5.4 Billion for the 12-month period ending March 2019. The product is available for shipping immediately.

About Cipla:

Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, anti-retroviral, urology, cardiology and CNS segments are well-known. Our 46 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT Mar'19), 3rd largest in the pharma private market in South Africa (IQVIA MAT Mar'19), and is among the most dispensed generic players in the US. For over eight decades, making a difference to patients has inspired every aspect of Cipla's work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the movement. A responsible corporate citizen, Cipla's humanitarian approach to healthcare in pursuit of its purpose of 'Caring for Life' and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. For more, please visit www.cipla.com, or click on TwitterFacebookLinkedIn.

 

SOURCE Cipla


These press releases may also interest you

at 20:05
Process Systems Enterprise (PSE), the leading supplier of Advanced Process Modelling (APM) software and services, today announced that it plans to be acquired by Siemens AG in a transaction scheduled to close in Q4 2019. The 160-strong PSE operation...

at 19:35
AVITA Medical , a regenerative medicine company focused on the development and commercialization of innovative therapies leveraging the healing properties of a patient's own skin, announced today that the U.S. Food and Drug Administration (FDA) has...

at 19:15
The "Competitor Analysis: Bispecific Antibodies for Immuno-Oncology & Other Diseases" report has been added to ResearchAndMarkets.com's offering. This report evaluates the landscape of investigational bispecific therapeutic antibodies for treatment...

at 19:14
How does Phoenix, Ariz. maintain the title of being the "most autism friendly city" in the world? To answer that question, you need to explore the constantly expanding Arizona network of autism resources and organizations dedicated to helping those...

at 18:47
Today at the Heart Failure Society of America Annual Meeting Dr. William T. Abraham the SMILE national principle investigator presented the results of the study as a late breaking trial. The study examined use of ReDStm non-invasive remote monitoring...

at 18:44
Softheon, a national leader in cloud-based health insurance exchange integration, announced today that the Centers for Medicare & Medicaid Services (CMS) approved them as one of the leading Phase 3 Enhanced Direct Enrollment (EDE) vendors. Softheon's...



News published on 22 july 2019 at 00:37 and distributed by: