Glenmark Receives FDA Approval for Norethindrone Tablets, Expanding US Contraceptive Portfolio

Glenmark Generics Inc., a subsidiary of Glenmark Generics Ltd, has received final approval from the US FDA for Norethindrone tablets 0.35mg, a generic version of Micronor tablets by Ortho McNeil Janssen Pharmaceuticals, Inc. This approval marks the company's third female hormonal product approval and second oral contraceptive approval, cementing its position as the only Indian company to have an ANDA approval for a female hormonal product and an oral contraceptive product. The approval comes on the heels of the company's recent approval for Norethindrone Acetate 5mg tablets and Heather tablets, a generic version of Watson's Nor-QD tablets.

Key Takeaways:

• Glenmark Generics Inc. has received final approval from the US FDA for Norethindrone tablets 0.35mg, a generic version of Micronor tablets.
• This approval marks Glenmark's third female hormonal product approval and second oral contraceptive approval.
• Glenmark remains the only Indian company to have an ANDA approval for a female hormonal product and an oral contraceptive product.
• The company has existing abbreviated new drug applications (ANDAs) pending approval with the US FDA, along with additional products in various stages of development within the oral contraceptive therapeutic segment.
• Glenmark's approval of Norethindrone tablets has expanded its presence in the US contraceptive market, which had sales of USD 4.5 billion in the 12-month period ending December 2009.

Statistics:

• Total sales of the niche generic contraceptive product were USD 43 million for the 12-month period ending March 2010, according to IMS Health.
• The US contraceptive market had sales of USD 4.5 billion in the 12-month period ending December 2009 (MIDAS sales data, IMS Health).
• Norethindrone tablets are a progestin-only oral contraceptive indicated for the prevention of pregnancy.

Sources:

• Glenmark Website: www.glenmarkpharma.com
• Contify.com