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Mylan Announced That Its U.S. Has Launched Mycophenolic Acid Delayed-Release Tablets

Jan 10, 2014

Mylan Inc. (Nasdaq: MYL) today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Mycophenolic Acid Delayed-release Tablets, 180 mg and 360 mg. This product is the generic version of Novartis' Myfortic® ...

Tags: Mylan, Mycophenolic Acid Delayed-release Tablets

Actavis Plc Has Received Approval From The U.S. FDA on ANDA

Jan 10, 2014

Actavis plc (NYSE: ACT) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Telmisartan Immediate-Release Tablets, 20 mg, 40 mg and 80 mg, a ...

Tags: Generic Version of Micardis, Actavis, Medicine News

United Therapeutics Obtained an Approval From FDA for Orenitram Extended-Release Tablets

Dec 24, 2013

US-based biotechnology company United Therapeutics has obtained an approval from the US Food and Drug Administration (FDA) for the Orenitram (treprostinil) extended-release tablets, indicted for the treatment of pulmonary arterial ...

Tags: Extended-Release Tablets, Medicine

FDA Has Approved Merck's Noxafil 100 Mg Delayed-Release Tablets.

Nov 29, 2013

The US Food and Drug Administration (FDA) has approved Merck's Noxafil (posaconazole) 100 mg delayed-release tablets. The tablets are a new formulation with a loading dose of 300mg (three 100mg delayed-release tablets) twice daily on the ...

Tags: Health, Medicine

LPI Has Launched Its Generic Rabeprazole Sodium Delayed-release Tablets,20mg

Nov 14, 2013

Lupin Pharmaceuticals (LPI), a US subsidiary of India-based Lupin, has launched its generic Rabeprazole Sodium delayed-release tablets, 20mg. Earlier, the company had received final approval from the US Food and Drug Administration (FDA) ...

Tags: Lupin Pharma, tablets

Mylan Has Obtained FDA Approval for sANDA for GSK's WELLBUTRIN XL

Aug 26, 2013

Mylan has obtained FDA approval for its supplemental abbreviated new drug application (sANDA) for the generic version of GSK's WELLBUTRIN XL, bupropion hydrochloride extended-release tablets USP (XL), 300mg. Bioequivalence study results ...

Tags: FDA Approval, drug application

Dr. Reddy's Laboratories Introduced Divalproex Sodium Extended Release Tablets

Aug 26, 2013

Integrated global pharmaceutical company Dr. Reddy's Laboratories has introduced divalproex sodium extended - release tablets, USP, in 250mg and 500mg strengths in the US. The new FDA approved product is the generic version of Depakote ER ...

Tags: Tablets, Medicine

Innopharma Has Introduced Acamprosate Calcium The Generic Version of Campral

Aug 19, 2013

Sterile product development company InnoPharma has introduced acamprosate calcium, 333mg delayed-release tablets, the generic version of Campral. The generic formulation of acamprosate delayed-release tablets was developed by InnoPharma, ...

Tags: Generic Version, Campral

Actavis Has Won FDA Approval for Abbreviated New Drug Application

Jul 16, 2013

Specialty pharmaceutical company Actavis has won FDA approval for abbreviated new drug application (ANDA) of generic equivalent to Endo Health Solutions' Opana ER. Oxymorphone Hydrochloride extended-release tablets, which is available in ...

Tags: FDA, ANDA, Generic Opana ER

TWi Pharmaceuticals Has Obtained FDA Tentative Approval for Its ANDA

May 16, 2013

Taiwan-based specialty pharmaceutical company TWi Pharmaceuticals has obtained FDA tentative approval for its abbreviated new drug application (ANDA) for Guanfacine Hydrochloride Extended Release tablets 1mg, 2mg, 3mg and 4mg. The central ...

Tags: TWi, FDA, pharmaceutical

FDA Approved Updated Labeling for Purdue Pharma L.P.'s Reformulated OxyContin Tablets

Apr 25, 2013

Posted by Jack Mans, Plant Operations Editor -- Packaging Digest, 4/23/2013 5:04:22 PM The U.S. Food and Drug Administration today approved updated labeling for Purdue Pharma L.P.'s reformulated OxyContin (oxycodone hydrochloride ...

Tags: Packaging, Printing

Astellas Has Introduced Myrbetriq as Overactive Bladder Therapy in Canada

Apr 12, 2013

Astellas Pharma Canada has introduced Myrbetriq (mirabegron, extended-release tablets) as overactive bladder (OAB) therapy in Canada. Myrbetriq is indicated to treat OAB with symptoms of urge urinary incontinence, urgency and urinary ...

Tags: Astellas Pharma, Bladder Medication, Medicine

Perrigo Has Commenced The Shipment of Guaifenesin 600mg Extended-Release Drug

Mar 21, 2013

Perrigo has commenced the shipment of Guaifenesin 600mg extended-release drug to its retail and wholesale customers in the process of its launch. Guaifenesin 600mg is a generic version of Mucinex 600mg extended release tablet, which ...

Tags: Health, Medicine

Santarus Has Announced The Commercial Launch of Ulcerative Colitis Therapy

Feb 19, 2013

Specialty biopharmaceutical company Santarus has announced the commercial launch of ulcerative colitis therapy, Uceris (budesonide) extended release tablets. Uceris that contains a locally acting glucocorticosteroid, budesonide, in a ...

Tags: Santarus, Uceris, ulcerative colitis therapy

Horizon Pharma Has Commenced The Full Commercial Launch of Rayos Delayed-Release Tablets

Feb 18, 2013

Specialty pharmaceutical company Horizon Pharma has commenced the full commercial launch of Rayos (Prednisone) delayed-release tablets for rheumatology indications, such as rheumatoid arthritis and polymyalgia rheumatica. Rayos is a ...

Tags: Horizon Pharma, Rayos, delayed-release tablets, rheumatology indications

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