Pharma

FDA Grants Warner Chilcott’s Petition on Asacol ANDAs

The FDA has granted a Warner Chilcott citizen petition, agreeing not to approve generic versions of the company’s ulcerative colitis drug Asacol that do not meet bioequivalence standards using in vitro dissolution and comparative pharmacokinetic (PK) data.

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Ranbaxy launches authorized generic version of Caduet® in the US

Ranbaxy has launched an authorized generic version of Caduet® in the U.S. market, as part of an agreement with Pfizer Inc. Caduet® generated total annual sales of US$339m in the U.S. (IMS – MAT September 2011). Ranbaxy is making available the full range of the generic version of Caduet®.

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Lupin receives US FDA nod for generic Solodyn tablets

Lupin Ltd has announced that it has received final approval for its minocycline hydrochloride extended release tablets 45 mg, 55 mg, 90 mg and 135 mg strengths as well as tentative approval for its minocycline HCl extended release tablets 65 mg, 80 mg, 105 mg and 115 mg strengths from the USFDA for the company's ANDA to market a generic version of Medicis’ Solodyn extended-release tablets with sales of US$750m as per IMS Sept 2011 data.

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Mylan launches generic version of Caduet tablets

Mylan announced that it has launched Amlodipine Besylate and Atorvastatin Calcium Tabs, the generic version of Pfizer's Caduet Tabs, which are used in the treatment of hypertension. Caduet Tabs had US sales of approximately US$339m for the 12 months ending Sept. 30, 2011, according to IMS Health. Mylan has started shipping this product.

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Ranbaxy announces launch of atorvastatin, generic Lipitor, in the US

Ranbaxy Pharma announced that it has received final approval from the USFDA to manufacture and market Atorvastatin and has launched the product in the US market. Mr. Arun Sawhney, CEO & MD, Ranbaxy, stated, “Atorvastatin helps millions of Americans manage healthy cholesterol levels, and we are pleased to have received USFDA approval.” Pursuant to an agreement between Ranbaxy and Teva, a portion of the profits from sales of Atorvastatin during Ranbaxy’s 180d FTF exclusivity period will be paid to Teva. Terms of the agreement were not disclosed.

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