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Sun Pharma’s generic atomoxetine pills (Strattera) wins tentative approval from US FDA

Thursday, November 26, 2009, 18:20 This news item was posted in Industry category and has 0 Comments so far.

Indian generic major Sun Pharma’s generic atomoxetine pills have won tentative approval from US FDA.

Sun Pharma’s atomoxetine hydrochloride capsules is the therapeutic equivalent version of Eli Lilly’s Strattera.

US FDA has granted a tentative approval for an Abbreviated New Drug Application (ANDA) for generic Strattera, atomoxetine hydrochloride capsules in seven strengths viz. 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg, Sun Pharma informed in a press release.

Atomoxetine hydrochloride capsules have annual sales of approximately USD 500 million in the US.

Strattera capsules are indicated for the treatment of attention deficit hyperactivity disorder.

A week ago, Sun Pharma was granted another tentative approval by US FDA to an
Abbreviated New Drug Application (ANDA) for generic Gleevec, imatinib mesylate tablets in  100 mg and 400 mg strengths.

Gleevec or imatinib mesylate, which is used for patients with chronic myeloid leukemia, has annual sales of approximately USD 950 million in the US.

Sun Pharmaceutical has also received final approval from the United States Food and Drug Administration (FDA) for nicardipine hydrochloride Injections (HCI), which is a short-term treatment for hypertension, this month.
Sun Pharma, India’s No. 1 drugmaker by market value, posted an 11.5% drop in net profit in July-September 2009, largely owing to fall in sales in its US subsidiary Caraco Pharma following seizure of products by US FDA.

Sun Pharma’s profits dropped to 4.54 billion rupees ($96 million) in its fiscal second quarter from 5.13 billion last year.

Sun Pharma’s net sales were 11.85 billion rupees, more or less similar to the figure 11.78 billion a year earlier.

Sun Pharma’s branded generic sale in India recorded sales at Rs 471 crores, registering a growth of 5% over same quarter last year and an increase of 51% compared to Q1 FY10, the immediate preceding quarter.

Sun Pharma holds 3.6% market share in the highly competitive Indian pharma market, as per latest IMS ORG report.

Overall,the company is ranked no. 1 based on share of prescriptions with 6 classes of specialists: psychiatrists, neurologists,cardiologists, ophthalmologists, orthopedics and gastroenterologists.

Sun Pharma launched 9 products in Indian market during the quarter, taking the total for the first half to 21.

Sun Pharma’s international generic sales (excluding Caraco) have grown by 29% over Q2 FY09, the same period last year.

Sun Pharma’s international API sales have grown by 15% over corresponding quarter last year.

US FDA seized all medicines made by Sun Pharma’s US subsidiary Caraco’s facilities in Detroit  after regulatory  officials found there had been repeated violations of manufacturing standards, in June.

Caraco signed a consent decree with the U.S. Food and Drug Administration in September, under which it cannot resume manufacturing until it gets a written notification from independent experts and the agency to do so.

Caraco’s sales in the September quarter fell 36 percent to $78.4 million following FDA action and the cessation of manufacturing.

“Performance across all business segments remains in line with our expectations, as borne out by the financials. Caraco, which signed a consent decree with the USFDA last month, continues to work towards regaining full cGMP compliance. We expect the core business momentum around growing profitably as well as developing, registering and launching new products to remain intact,” stated Dilip Shanghvi, chairman and managing director of Sun Pharma.

Sun Pharma and Caraco got US FDA approvals for 79 ANDAs. In the second quarter, ANDAs for 3 products have been filed between Sun Pharma and Caraco. This takes Sun Pharma total ANDA filings to 11, in the first half. During the second quarter, ANDAs for 6 products from Sun Pharma have been approved. ANDAs for 108 products now await USFDA approval, including 10 tentative approvals. This pipeline is expected to build revenues for our US generic business in the years ahead, Sun Pharma said in an official release announcing quarterly results.

Sun Pharma’s consolidated R&D expense for Q2 FY10 is Rs. 62 crores, or 5% of net sales. For the first half, the consolidated R&D expense is Rs. 139 crores, or 7% of net sales.

Sun Pharma has made a cumulative of 144 DMF / CEP applications, with 84 approved so far.

The total number of patent applications submitted for Sun Pharma now stands at 239 with 76 patents granted so far.

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