Financial Daily from THE HINDU group of publications
Friday, Dec 27, 2002
Ranbaxy gets FDA nod for Isotretinoin
NEW DELHI, Dec. 26
RANBAXY Laboratories Ltd today announced that it has been granted approval by the US Food and Drug Administration (FDA) to manufacture and commercialise Isotretinoin capsules in potencies of 10, 20 and 40 mg.
Based on pharmacokinetic studies, the Ranbaxy formulation, approved on December 24, has been deemed to be AB rated and therapeutically equivalent to `Accutane' capsules in 10 mg, 20 mg and 40 mg, respectively.
Isotretinoin capsules, according to a Ranbaxy press statement here, are indicated for severe recalcitrant nodular acne. Overall sales of Accutane in the US totalled $523 million during the year.
According to Mr D.S. Brar, CEO & Managing Director, Ranbaxy Laboratories, Isotretinoin represents yet another significant milestone for the company for the year.
Ranbaxy has been actively engaged in the preparation to launch Isotretinoin in the US which, among other things, includes elaborate patient monitoring and patient education programmes.
The final plans were in the process of being firmed up, the statement said.
Ranbaxy Laboratories, the country's largest pharmaceutical company, manufactures and markets branded generic pharmaceuticals and active pharmaceutical ingredients.
Its continued focus on research and development (R&D) has resulted in several approvals in developed markets and significant progress in new drug discovery research.
Ranbaxy's foray into `Novel Drug Delivery Systems' has led to several proprietary "platform technologies" resulting in many products under developmental stages.
The company was selling its products in over 100 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 25 countries and manufacturing operations in seven countries, the statement said.
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