Mylan Inc. announced that its subsidiary Bioniche Pharma has launched Octreotide Acetate Injection USP, Pre-Filled Syringes (PFS), the generic version of Novartis' Sandostatin, a treatment for a rare hormonal disorder called acromegaly. Octreotide Acetate Injection is also used to suppress or inhibit severe diarrhoea associated with metastatic carcinoid tumours and vasoactive intestinal peptide tumours.
Mylan Institutional president Matt Erick said: “This approval is particularly important because it is the first and only PFS for this product — brand or generic — providing hospitals and clinics access to a preferred presentation that offers ease, accuracy and convenience of dosing. The addition of Octreotide Acetate Injection as Mylan Institutional's first PFS is a critical next step in expanding our already diverse portfolio of injectable products.”
Octreotide Acetate Injection had US sales of approximately $579 million for the 12 months ending Dec. 31, 2010, according to IMS Health. The product, which is available for immediate shipment, was developed by Chemi and is being manufactured by Italfarmaco; both companies are part of privately held Italian Pharmaceutical Group.
Bioniche Pharma is part of Mylan Institutional, a platform that provides differentiated pharmaceutical products to institutional customers throughout North America. Mylan Institutional's product offering includes the specialty injectables of Bioniche Pharma with the unit dose capabilities of Mylan's UDL Laboratories. Mylan Institutional's customers include group purchasing organizations, wholesalers, hospitals, surgical and radiology services, home infusion service providers, long-term care facilities, correctional facilities, specialty pharmacies, veterinary clinics and retail outlets.
Currently, Mylan has 168 ANDAs pending FDA approval representing $98.7 billion in annual sales, according to IMS Health. Forty-eight of these pending ANDAs are potential first-to-file opportunities, representing $25.9 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health.
Mylan Inc. maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and focused on respiratory, allergy and psychiatric therapies.