NATCO Pharma Limited is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved its marketing partner Mylan’s Abbreviated New Drug Applications (ANDAs) for Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection, an AP-rated, substitutable generic version of Teva’s Copaxone® 40 mg/mL, and Glatiramer Acetate Injection 20 mg/mL for once-daily injection, an AP-rated, substitutable generic version of Teva’s Copaxone® 20 mg/mL, which are indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system. The launch plans for both products will be communicated shortly after concurring with its partner Mylan.
Copaxone® is the most prescribed MS treatment for relapsing forms of MS in the United States with brand sales for the 20 mg/mL dose of approximately $700 million and for the 40 mg/mL dose of approximately $3.64 billion for the 12 months ending July 31, 2017, according to Quintiles IMS. Approximately 400,000 individuals in the U.S. have MS and relapsing MS accounts for 85% of initial MS diagnoses.
Natco Pharma Limited is pleased to announce the final approval of Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base). The product, as the first generic, will be launched shortly in the USA market.
Natco’s Lanthanum Carbonate strengths mentioned above are generic equivalents of Shire Development LLC’s Fosrenol® Chewable Tablets and are indicated to reduce serum phosphate in patients with End Stage Renal Disease (ESRD).
Fosrenol® Chewable Tablets has US sales of USD 122.4 million (IMS MAT June 2017). Lupin and Natco had entered into an agreement on September 01, 2008 to jointly commercialize generic equivalents of Fosrenol® Chewable Tablets.
NATCO Pharma Limited along with its partner Dr. Reddy's Laboratories is pleased to announce U.S. Food and Drug Administration (USFDA) approval for the launch of Doxorubicin Hydrochloride Liposome Injection in the U.S. Market.
The product is a therapeutic equivalent generic version of Doxil®(doxorubicin hydrochloride liposome injection), for intravenous use, in the United States market.