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Ranbaxy gets FDA approval for analgesic combine

Our Bureau

NEW DELHI, Nov. 29

RANBAXY Pharmaceuticals Inc, a wholly-owned subsidiary of Ranbaxy Laboratories Ltd, has received US FDA approvals for acetaminophen and codeine phosphate tablets.

These are therapeutic equivalents of tylenol and codeine tablets, which are originally registered with Ortho McNeil Pharmaceutical Inc.

The US-FDA approvals are for acetaminophen and codeine phosphate tablets USP, 300 mg/30 mg and 300 mg/60 mg and they combine the analgesic effects of a centrally-acting analgesic, codeine, with a peripherally acting analgesic, acetaminophen, to target se vere pain, according to an official press communique.

The two analgesics clocked sales of $81.4 million in 2000. The final dosage form will be manufactured and packaged at Core Pharma LLC, Middlesex, New Jersey and ultimately marketed through Ranbaxy Pharmaceuticals Incs sales and marketing organisation.

Acetaminophen and codeine phosphate tablets USP will be launched immediately through retail pharmacy outlets, hospitals and generic distributors nationwide.