Orchid Pharma gets US FDA approval for generic zaleplon to treat insomnia

Indian generic firm Orchid Chemicals & Pharmaceuticals has received approval from US FDA for its generic version of zaleplon pills used in the treatment of insomnia or sleeplessness.

Orchid has received the final approval for its abbreviated new drug application (ANDA) relating to zaleplon capsules in strengths of 5 mg and 10 mg from the US Food and Drug Administration, the company said in an announcement.

Zaleplon is marketed under the brand names Sonata and Starnoc is a branded product of the US-based King Pharmaceuticals Inc.

Zaleplon is a hypnotic or sedative medication that induces sleep. Zaleplon is used for treating insomnia.

Zaleplon does not belong to the widely used sedative benzodiazepine class of medications for sleep, e.g. lorazepam (Ativan), oxazepam (Serax), flurazepam (Dalmane), triazolam (Halcion), and temazepam (Restoril). However, zaleplon has similar effects because it attaches to the same receptors on nerve cells like benzodiazepine class of medications.

Zaleplon is found safer sedative in studies and not causing an increase in road traffic accidents as compared to other hypnotics currently on the market.

Zaleplon was approved by the FDA in 1999.

The capsules are in strengths of 5 mg and 10 mg and are used in treating insomnia, the filing added.

With this approval, the total ANDA approval count of Orchid has gone up to 37 while the total ANDA
filings stand at 58, the company said.

Most recently, Orchid Chemicals received approvals from US FDA for its antibiotic combination piperacillin and tazobactam for injection, with 180-day exclusivity to market the products in US.

Orchid Pharma got approvals covering its generic equivalents in 2.25 g, 3.375 g and 4.5 g vial as well as 40.5 g dosage forms and strengths, the company announced in a press release.

Piperacillin and tazobactam for injection is an injectable combination product consisting of the semisynthetic antibiotic piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration.

In July, Orchid Chemicals & Pharmaceuticals Ltd  received approval from the US FDA for its generic version of Pfizer’s  anti-hypertension pill amlodipine besylate (Norvasc) in  2.5 mg, 5 mg and 10 mg strengths, Orchid said in press release.

Orchid received tentative approval from the US Food and Drug Administration (US FDA) for its migraine pill sumatriptan succinate, in May.

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.

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.