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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

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

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

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

Santarus Has Obtained FDA Approval for Ulcerative Colitis Therapy

Jan 16, 2013

Santarus has obtained FDA approval for ulcerative colitis therapy, Uceris (budesonide) extended release tablets. A 9mg dose tablet is approved for administration once a day in adult patients with ulcerative colitis for up to eight weeks. ...

Tags: Santarus, FDA approval, ulcerative colitis therapy

Mylan Has Been Sued Jointly by Pfizer,Wyeth Pharmaceutical,Wyeth LLC and PF Prism

Dec 7, 2012

Mylan has been sued jointly by Pfizer,Wyeth Pharmaceutical,Wyeth LLC and PF Prism regarding the filing of an abbreviated new drug application (ANDA) with the US food and drug administration (FDA) for desvenlafaxine succinate ...

Tags: Mylan, desvenlafaxine succinate extended-release tablets, MDD

Actavis Group Gained FDA Approval for Ropinirole Extended-Release Tablets

Dec 7, 2012

Actavis Group, a generic pharmaceuticals company, has gained FDA approval for Ropinirole extended-release tablets, 2mg, 4mg, 6mg, 8mg and 12mg. The company has started distribution of the generic version of GlaxoSmithKline's Requip XL. ...

Tags: Actavis Group, ropinirole extended-release tablets

GSK and XenoPort Have Gained FDA Approval for Horizant Tablets for PHN

Dec 6, 2012

GlaxoSmithKline (GSK) and XenoPort have gained FDA approval for Horizant (gabapentin enacarbil) extended-release tablets for postherpetic neuralgia (PHN). A single 12-week principal efficacy trial and two supportive studies that met their ...

Tags: Horizant extended-release tablets

Zalicus Received The US FDA Approval for sNDA

Dec 5, 2012

Biopharmaceutical company Zalicus has received the US FDA approval for its supplemental new drug application (sNDA) for the 32 mg dose strength of Exalgo(hydromorphone HCl) Extended-Release Tablets (CII). Exalgo is used to treat moderate ...

Tags: Exalgo Extended-Release Tablets, around-the-clock opioid analgesia

FTC Approval for Its Acquisition of The Actavis Group of Companies

Dec 4, 2012

Watson Pharmaceuticals has received the US Federal Trade Commission (FTC) approval for its acquisition of the Actavis group of companies. The approval is the result of Watson's agreement to a proposed consent order to divest certain ...

Tags: Watson Pharmaceuticals, FTC, Federal Trade Commission

Mylan Has Launched Lithium Carbonate Extended-Release Tablets USP

Nov 29, 2012

Mylan has launched Lithium Carbonate Extended-release Tablets USP, 450 mg following the final approval from the US Food and Drug Administration (FDA). The drug is used to treat manic episodes of manic depressive illness. According to ...

Tags: Mylan, lithium carbonate extended-release tablets, treat manic episodes

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