The Hindu Business Line : Dr Reddy's files in US for migraine drug

DR Reddy's Laboratories on Wednesday announced that it had filed an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration (USFDA) for Sumatriptan Succinate oral tablets used for tackling migraine.

Dr Reddy's notified the same to GlaxoSmithKline and in response the latter filed a lawsuit in the United States District Court for the Southern District of New York claiming that Dr Reddy's had infringed on its Patent `845.

Sumatriptan Succinate is the generic version of GlaxoSmithKline's `Imitrex' and is indicated for the treatment of migraine. The brand had annual sales in the United States of approximately $773 million, according to a press release from Dr Reddy's.

Dr Reddy's Sumatriptan Succinate tablets are of 25 mg, 50 mg and 100 mg base and the ANDA application refers to Paragraph IV certification on four of the five Orange Book patents listed for the drug.

More Stories on : Announcements | Pharmaceuticals | Regulatory Bodies & Rulings

Article E-Mail :: Comment :: Syndication :: Printer Friendly Page

Stories in this Section
Lupin files new drug application for psoriasis

Dr Reddy's files in US for migraine drug

MECON bags 3 highway projects

Jindal meet on Jan 27

Correction

Singapore co also to invest in Matrix Labs

`Cos not obliged to have nominee directors on remuneration panel'

Bharti `all set' to acquire Escotel — First Pacific Company may also sell out stake

K Sera Sera to offer shares to Sahara India

Andhra Sugars, Krebs in pact with loss-making units

Will manufacturing emerge from services shadow?

Suven gets ISO certification

Uncertainty over FACT debt burden continues

Singareni plans 12 more mines