Barr launches generic Fosamax 70 mg tabs
Barr Pharma has launched a generic version of Mercks Fosamax (Alendronate Sodium trihydrate) Tablets, 70 mg after receiving final approval from the USFDA. The FDA approved the company's application on February 6, 2008, following the expiration of paediatric exclusivity (PED) associated with the earliest to expire of the patents listed with the FDA for Fosamax, 70 mg tablets. Barr obtained favourable resolutions with regard to the other patents listed for this product. Barr is entitled to share 180 days of marketing exclusivity for its 70 mg Alendronate Sodium product. This exclusivity bars the entry of competition for this product against generic competitors, other than an authorized generic and another company with which Barr shares exclusivity.Barr's Alendronate Sodium product is indicated for the treatment and prevention of osteoporosis in postmenopausal women; for the treatment to increase bone mass in men with osteoporosis; for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density; and for the treatment of Paget's disease of bone in men and women.Fosamax Tablets, 70 mg had annual sales of approximately $1.7 billion in the United States, based on IMS sales data for the 12 months ending November 2007.
King launches Altace tablets
King Pharma launched its new Altace tablets (Ramipril). King has also received orders and initiated shipments of Altace tablets to many of its customers. The company will continue to make available Altace capsules.Altace is the leading branded ACE inhibitor with multiple indications. Altace is indicated for the treatment of hypertension. Altace has also been shown to reduce the risk of death in stable patients who have demonstrated clinical signs of congestive heart failure within the first few days after sustaining acute myocardial infarction.
Orchid gets US FDA nod for cefuroxime tabs
The Chennai-based pharma company Orchid has received approval from the USFDA for its ANDA for cefuroxime axetil tablets. The product is available in three dosage strengths, 125 mg, 250 mg and 500 mg. This is the 25th ANDA approval that Orchid has received since it started its US generics journey in 2005. Ranbaxy has also approved ANDA on this product
Wockhardt consolidated net up by 23% in fourth quarter
Wockhardt has achieved good consolidated performance during the fourth quarter ended December 2007. The company's consolidated net profit for the quarter ended December 2007 increased by 22.7 per cent to Rs 106.90 crore from Rs 87.10 crore in the corresponding period of last year despite reduction in other income and significant growth in staff cost. The consolidated net sales increased by 44.8 per cent to Rs 762 crore from Rs 526.40 crore in the similar period of last year. For the full year ended December 2007, the company's consolidated net profit increased by 59.9 per cent to Rs 385.80 crore from Rs 241.30 crore in the previous year. Its consolidated net sales increased by 53.5 per cent to Rs 2653 crore from Rs 1729 crore. The staff cost went up by 75 per cent to Rs 443.30 crore from Rs 253.20 crore. Further its R&D expenditure reached at Rs 50.50 crore.
