Indian pharma major Dr Reddy’s Laboratories has withdrawn certain lots of generic risperidone tablets from the US market due to quality concerns.
Dr Reddy’s has recalled 78,876 bottles of risperidone in 2mg and 4mg strengths from the US market, reports said.
The company has voluntarily recalled lots of risperidone 2 mg and 4 mg, 60-count bottles due to out of specification results observed during stability testing.
Risperidone 2 mg and 4 mg represent approximately 0.1 per cent of total North America Generic sales.
Risperidone, sold by Janssen-Cilag under the trade name Risperdal, is used in psychiatric medicine to treat cases of Schizophrenia, a form of insanity. It acts on certain specific receptors on the brain that helps to modify the behavior of persons so afflicted.
Maybe, this is the second time that Dr Reddy’s is recalling risperidone pills from the US market.
In September 2009, Dr. Reddy’s Laboratories Ltd had recalled risperidone tablets along with citalopram,fexofenadine, pravastatin in certain strengths from US market, following concerns of on the size and proportion of these pills which are found to be above the stipulated standard size norms.
Dr Reddy’s recalled product list consists of citalopram 40 milligram in bottles of 100 tablets, fexofenadine 180 mg in bottles of 500 tablets, pravastatin 10 mg in bottles of 90 and 500 tablets and risperidone (plain) 25 mg in bottles of 500 tablets.
Dr Reddy’s was voluntarily recalling four products from the U.S. market as a precaution as some lots contained oversized tablets, the company said.
“Our investigation suggests that the issue is isolated to four products, one specific lot per product, four lots in total,” a company spokesperson was quoted as saying.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration, the company said, adding, there will be no material financial impact from the recall.
Fexofenadine hydrochloride is the AB-rated generic equivalent of Sanofi-Aventis’ Allegra. Allegra is indicated for the relief of symptoms associated with seasonal allergic rhinitis and for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. Allegra recorded annual US brand sales of approximately $1.4 billion in 2005, as per IMS.
Citalopram hydrobromide, the generic equivalent of Forest Laboratories’ Celexa, is indicated for the treatment of depression. Celexa has annual US brand sales of approximately $1.4 billion.
Pravastatin is a medication that has been licensed to treat several conditions including high cholesterol (hypercholesterolemia), high triglycerides and heart disease and heart-related problems.
Pravastatin is sold under the brand name Pravachol by Bristol-Myers Squibb. In April of 2006, the U.S. Food and Drug Administration approved a generic pravastatin.
Dr Reddy`s Labs received final approval from the US Food and Drug Administration (USFDA) to market risperidone tablet in the strength of 0.5 mg and 2 mg in March.
Hyderabad-based Dr. Reddy’s Laboratories is an emerging global pharmaceutical company. Dr Reddy’s has three core businesses: Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products. Our products are marketed globally, with a focus on India, US, UK, Germany and Russia.
Dr Reddy’s has been in financial troubles due to supply constraints for its German Subsidiary, Betapharm for quite some time.
Dr Reddy’s Laboratories posted a 3.76 per cent drop in net profit at Rs 156.1 crore for the fourth quarter ended March 31, 2009, as compared to Rs 162.2 crore in the corresponding period a year ago.Dr Reddy’s gross earnings rose by 12.36 per cent to Rs 1,166.5 crore for the quarter under review as against Rs 1,038.1 crore.
As per the audited consolidated results, the group has posted a net loss attributable to the shareholders of the parent of Rs 917.2 crore for the year ended March 31, 2009 as compared to a net profit of Rs 438.1 crore for the previous corresponding year.
Dr Reddy’s has written down $290 million against its German unit Betapharm resulting in a March quarter loss.
In June, DRL had agreed to supply GSK with over 100 branded drugs to be sold in Africa, west Asia, Asia Pacific and Latin America.
As per agreed terms, the products will be manufactured by Dr. Reddy’s and will be licensed and supplied to GSK in various emerging markets excluding India. Revenues will be reported by GSK and will be shared with Dr. Reddy’s . In certain markets products will be co-marketed by Dr. Reddy’s and GSK.