Orchid drug gets USFDA nod

Orchid Chemicals and Pharmaceuticals on Wednesday announced that it has received permission from the US regulator to sell the injectible Ceftriaxone over there.

Ceftriaxone went off patent on July 19, 2005, and Orchid is the third generic company to have received permission to sell the drug.

The US Food and Drug Administrations (FDA) approved Orchid's Abbreviated New Drug Application (ANDA) for Ceftriaxone in the following strengths: 250 mg, 500 mg, 1 gm and 2 gm single-dose vials; 1 gm and 2 gm piggyback vials and 10 gm/100ml pharmacy bulk package vials.

Ceftriaxone is the third Orchid drug to be cleared by the US FDA for sale there. The drugs cleared earlier, Cefazolin and Cephalexin, also belong to the therapeutic segment of antibiotics.

Orchid's Ceftriaxone will be distributed in the US by Apotex, which struck a deal with the company in 2003 to distribute 8 injectibles there. Ceftriaxone is the second injectible covered by the deal (Cefazolin was the first).

In all, Orchid has sewn up deals for distribution of 15 antibiotics in the US. Of the 15, eight are to be injectible, all of which are to be distributed by Apotex. It also has a distribution deal with Par Pharma for seven antibiotics in oral form. Orchid's statement said the company has as of date filed 19 ANDAs with the US FDA.

Earlier, Orchid's managing director K Raghavendra Rao told Business Standard that the company expected to eventually generate a revenue of about Rs 650 crore from the marketing tie ups for the 15 antibiotics.