Orchid gets US FDA approval for amlodipine (Norvasc) generic pills

Indian generic firm Orchid Chemicals & Pharmaceuticals Ltd  has received approval from the US FDA for its generic version of Pfizer’s  anti-hypertension pill amlodipine besylate (Norvasc).

USFDA has granted approval for the Chennai-based Orchid’s ANDA (Abbreviated New Drug Application) for amlodipine besylate tablets in  2.5 mg, 5 mg and 10 mg strengths, Orchid said in press release.

Amlodipine  is a long-acting calcium channel blocker belonging to the dihydropyridine class of drugs. Amlodipine is  used as an anti-hypertensive and in the treatment of angina.

Similar to other calcium channel blockers, amlodipine acts by relaxing the smooth muscle in the arterial wall. It decreases the peripheral resistance in the blood vessels and reduces blood pressure. In angina amlodipine  increases blood flow to the heart muscles.

Amlodipine besylate is the most prescribed high blood pressure medicine worldwide.

Sold in the brand name Norvasc by Pfizer in North America, Australia and some European countries, amlodipine is marketed as Dailyvasc in the Philippines by Xeno Pharmaceuticals and as Istin in the United Kingdom. Generic brands –such as Perivasc in Australia –are also available.

With this approval, Orchid’s cumulative ANDA approval count stands at 32 and the total ANDA filing count stands at 58, the company statement said.

In May,  Orchid Chemicals & Pharmaceuticals Ltd  received tentative approval from the US Food and Drug Administration (US FDA) for its migraine pill sumatriptan succinate.

Orchid Chemicals & Pharmaceuticals Ltd registered a turnover and operating income of Rs 1211.27 crore for the fiscal year ended March 31, 2009 compared to the previous year’s revenues of Rs 1240.14 crore.

The company registered a loss after tax of Rs 52.17 crore as against a profit after tax of Rs 184.54 crore registered during the last fiscal.

Earnings before Interest & Tax (EBIT) stood lower at Rs 157.77 crore compared to Rs 248.40 crore of the last fiscal.

The fiscal 2008-09 witnessed a plateau in the US generics business of Orchid. The dip is partly attributed to the overall recession in the US economy with the distributors and trade channels at large being cautious with orders.

Orchid received approvals from several countries in EU for launch of Piperacillin-Tazobactam Injections in the financial year 2008-09.

During the period, Orchid’s cumulative ANDA filings moved to 58 with 29 of the filings in the cephalosporins space, 5 in Betalactams, 21 in the NPNC segment and 3 in the Penems segments. These also include 7 Para IV FTF (First-to-File) ANDA filings.

In the Canadian market, Orchid’s cumulative count of ANDS approved moved to 5 with the recent approval received for Cefepime Arginine Injections. Of the total ANDS approved, 4 are in Cephalosporin Segment and 1 in the Betalactam segment.

Orchid’s cumulative filing count of Marketing Authorizations (MA) in the EU region moved to 29. Of these MA filings, 23 are in the cephalosporin segment, 1 in the penicillin injections segment, 2 in Carbapenem Segment and 3 in NPNC segment.  Orchid has cumulatively received 19 MA approvals so far.

In the Active Pharmaceutical Ingredients (API) segment, Orchid increased the cumulative filings of its US DMF count to 72. The break-up of the total filings is 26 in the cephalosporin segment, 33 in NPNC segment, 2 in the betalactam segment and 11 in the carbapenems segment.

In the European market, the cumulative filings of CoS (Certificate of Suitability) count remained at 20 which includes 12 in cephalosporin segment, 7 in NPNC segment and 1 in the betalactam segment.

Orchid had also made its first Japanese DMF filing during the fourth quarter of the fiscal under review. The cumulative DMF filing count in Japan as of date stands at 3, according to company statements.