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Suppliers Are Bringing New Generic Options to Marketplace.

NEW YORK--A recent burst of approvals and launches of new generic drugs aims to boost competition and offer patients more economical options for their prescription medicines.

Aurobindo Pharma Ltd. has received final approval from the Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for capecitabine tablets USP, 150 mg, and 500 mg. Aurobindo's capecitabine tablets are an AB-rated generic equivalent to the reference listed drug Xeloda. Capecitabine tablets are indicated for the treatment of adjuvant colon cancer, metastatic colorectal cancer and metastatic breast cancer.

Capecitabine tablets represent the latest addition to Aurobindo's broad line of vertically integrated generic pharmaceuticals. Aurobindo's product portfolio consists of 315 final approvals, including 35 tentative approvals, and 17 approved products from Aurolife. There are 98 additional products on file with the FDA.

Meanwhile, Lupin received final approval from the FDA for its tetrabenazine tablets, 12.5 mg and 25 mg, a generic version of Valeant Pharmaceuticals North America's Xenazine tablets, 12.5 mg and 25 mg. These medicines are used for the treatment of chorea associated with Huntington's disease.

Amerigen Pharmaceuticals Ltd. and Dipharma Francis Sri announced the ANDA approval for Miglustat 100 mg capsules, the first generic version of Actelion's Zavesca.

Miglustat, a glucosylceramide synthase inhibitor, is indicated as monotherapy for the treatment of adults with mild to moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option (e.g., due to allergy, hypersensitivity or poor venous access).

Ultragenyx and Kyowa Kirin reported that Crysvita (burosumab-twza) was approved as the first treatment for patients age 1 year or older with X-linked hypophosphatemia (XLH), a rare, inherited form of rickets that causes low levels of serum phosphorous. Crysvita, a recombinant fully human monoclonal IgGl antibody, works by blocking fibroblast growth factor 23 (FGF23), a hormone that causes phosphate urinary excretion and suppresses vitamin D production by the kidney. This results in increased phosphate reabsorption from the kidney and increased vitamin D production, enhancing intestinal absorption of phosphate and calcium.

Lastly, Dr. Reddy's Laboratories has launched levocetirizine dihydrochloride tablets 5 mg, an over-the-counter allergy medication, in the U.S. market.

Dr. Reddy's said its levocetirizine dihydrochloride tablets are a generic version of Xyzal Allergy 24HR Tablets from Chattem-Sanofi. The 5 mg Dr. Reddy's product comes in various consumer-oriented package sizes.

An antihistamine, levocetirizine dihydrochloride tablets (5 mg) are indicated for 24-hour relief of allergy symptoms such as watery eyes, runny nose, itching eyes and nose, and sneezing.

Xyzal Allergy 24HR Tablets had U.S. sales of approximately $71 million for the 12 months through January 2018, according to IRI market data reported by Dr. Reddy's.

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Title Annotation:Generic Drugs
Publication:Chain Drug Review
Date:May 14, 2018
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