Ranbaxy recalls one batch of one of the Ranbaxy’s largest selling pills – Sotret – following US FDA recommendation.
India’s Ranbaxy Laboratories has withdrawn a single lot of its acne drug Sotret (isotretinoin) from the US market, in a major set back to the company’s one of the top selling drugs.
Ranbaxy has voluntarily recalled a single lot of Sotret (isotretinoin) capsules of 40 milligram strength from the US market, the company said in a statement.
Sotret Isotretinoin is used for treating skin infections including acne.
Isotretinoin is the original product of Roche sold under the brand name Accutane. Accutane generics are marketed under various trade names, Amnesteem (Mylan), Claravis (Barr), Clarus (Prepharm), Decutan (Actavis), Isotane (Pacific Pharmaceuticals), Izotek (BlauFarma), Oratane (Genepharm Australasia), Roaccutane (Roche). Topical solutions of isotretinoin is most commonly marketed under the trade names Isotrex or Isotrexin (Stiefel).
US FDA approved Ranbaxy’s generic version of isotretinoin in 2003. Sotret has an annual sale of around $415 million in the US.
Generic drugs maker Ranbaxy Laboratories, which has been acquired by the Japanese Daiichi Sankyo, stated Ranbaxy Laboratories Inc Priceton NJ is conducting a voluntary recall of Sotret Isotretinoin capsules, USP 40 mg, which is limited to Lot No 1876849, currently available in the US market.
Ranbaxy has recalled Sotret on the US health regulator Food and Drug Administration’s (FDA’s) recommendation, the company said.
“Based on the US FDA’s testing and recommendations, and out of an abundance of caution; a recall has been initiated to the wholesaler/distributor level,” Ranbaxy was quoted as saying.
However, Ranbaxy said that the Sotret recall is a Class III recall, which signifies that the use of, or exposure to, the product is not likely to cause adverse health consequences.
However, the company clarified that this is a class III recall, which signifies that the use or exposure to the product is not likely to cause adverse effects.
Ranbaxy Laboratories has, recently, acquired trademarks, product dossiers and marketing rights from Ochoa Laboratories Limited for its entire range of dermatological and lifestyle products, as part of its efforts to consolidate its position in skincare segment.
Of late, US FDA has issued warning letters to seven APIs and 30 generic drugs (sterile and non-sterile) of RLL, manufactured at its Dewas and Paonta Sahib manufacturing facilities for non-confirming to cGMP norms. (see the list of the API and generic formulations below).
Ranbaxy Laboratories Ltd reported net loss of 7.78 billion rupees ($156 million) in its fiscal first quarter ended March 2009, compared with a profit of 1.03 billion rupees in the year-ago quarter.
Ranbaxy Laboratories Ltd also said it anticipated a loss of $150 million on sales of $1.4 billion in the year ending December 2009.
Ranbaxy, in which Japan’s Daiichi Sankyo owns about 64 percent, posted losses because of wrong-way bets on foreign- currency hedges as the Indian rupee weakened against the dollar for the fifth straight quarter.
Ranbaxy’s sales in the US, the world’s largest drug market, also dropped 14 percent.
In January 2009, Ranbaxy’s chairman Malvinder Singh is reportedly said the company may shift some generic drug production to the U.S. from India or buy factories approved by the FDA in response to the US import ban.
Ranbaxy’s sales in North America, which accounts for about 27 percent of Ranbaxy’s revenue, fell 7 percent to 4.04 billion rupees in the fourth quarter of financial year 2008-2009. Sales in the U.S. declined to 3.4 billion rupees. Ranbaxy also said sales dropped 14 percent in Europe, and gained 9 percent in India.
Ranbaxy reported 9.19 billion rupees as losses on foreign-currency options before tax. The company also wrote down the value of convertible bonds due 2011 as the Indian currency weakened 3.9 percent against the dollar in the three- month period, its fifth straight quarterly decline.
List of API and formulations covered under warning letters
Fosinopril Sodium and Hydrochlorothiazide
Nitrofurantoin;Nitrofurantoin and Macrocrystalline