The mazda pharma Guide 5th August to 11th August 2013

? ? PHARMACEUTICAL ARTICLE new generic pharmaceuticals business,” said Ketan Mehta, president and CEO of TrisPharma.“With 13 FDA-approved ANDA products and a robust pipeline of ANDA development projects, we look forward to launching many more difference-making specialty generics,” said Janet Penner, president of Tris' generic pharmaceuticals business.Manufactured at Tris' US Food and Drug Administration (FDA)-inspected, state-ofthe-art facility in Monmouth Junction, NJ, dextroamphetamine sulfate oral solution is now available in the US through wholesalers and distributors, as well as directly to the trade. Dextroamphetamine sulfate oral solution was approved by the FDA on May 29, 2013. It is distributed in accordance with FDA and US Drug Enforcement Administration (DEA) regulations governing the handling of CII controlled substances. COMMERCIALISATION OF HP ACTHAR GEL TO TREAT SYMPTOMATIC SARCOIDOSIS : Questcor Pharmaceuticals, Inc., a biopharmaceutical company, to initiate a pilot commercialisation effort for HP Acthar Gel (repository corticotropin injection) for the treatment of respiratory manifestations of symptomatic sarcoidosis, a potentially serious, difficult-to-treat disorder already included on the FDA-approved package insert for Acthar. The pilot effort will focus on pulmonologists, who are the respiratory specialists treating this rare autoimmune disorder. The company anticipates hiring and training a small, pilot sales force of five to ten sales representatives during the current quarter, with introductory sales calls expected to begin in the fourth quarter of this year. While this approach mirrors the pilot commercial efforts by Questcor in neurology, nephrology and rheumatology, there can be no assurance that this initiative will lead to a fully-sized pulmonology sales force or that the company's efforts with respect to this disorder will otherwise be successful. Questcor is also evaluating several potential clinical studies that have been recently proposed by key opinion leaders in the sarcoidosis field. "This commercial expansion, together with our increasing R&D investment, continues our efforts to expand patient access to the FDA-approved, on-label indications of Acthar," said Don M Bailey, Questcor's president and chief executive officer. "Already, patients suffering from nephrotic syndrome (NS), multiple sclerosis (MS) exacerbations, infantile spasms, and certain rheumatologyrelated conditions have benefitted from Acthar. Our plans to increase awareness among pulmonologists treating patients suffering from respiratory manifestations of symptomatic sarcoidosis will follow the model we have used successfully for these other markets as we continue to explore the full therapeutic potential of Acthar." "We are experiencing solid uptake of Acthar in rheumatology including, most recently, a larger than expected number of prescriptions for rheumatoid arthritis, an additional on-label in X?][?[?\?H?X?Z]?[????]]?H?YY?X?????H\?X?X[??[?H?][X]???H??[][?]K???[Y[?Y?]?H?\??YY??\?][????X?\??]Y\??????\?Y?\?X\?H?X??\??[??\??X???X????X??\??[[??H[??][\H?]?X?\?X\??]??H\?HX??[\?][???\?[????Y?[?H[?Y?????X?\??][[????\???[]Y[???Y??\?[?????H?[\?X]X??\???Y??\??H?[\?HH?X[??\??]?X?\??X?X[\????Y?[??[[???[?YX?][??[[????\??X??]X?\?[?]??[?X[??H[?H?X]Y[??\?Y??X?[]?]?X]]]?[[][?H\??\??\??H]?H?X??\??[H?H[?H\??]?\?T???[??][X]???H??[Y\??X[Y?????H^X???Z[??[XX?H[???X][????H\?[?]X[[?Y????X??[[???H?\??[?X[?^?\?[?H??[Y\??X[\?][????\????\???Y??\?\?H?\?[ZX?[??[[X]?H\?X\?H?\?H?[??[\???[?[?X\??[?X[?Y?\?[?][\H??[??[???[?[?H[????\???Y??\??[??HY??X?[??X][?Y????X]Y?X??\??[K?\?[?\?X[\??Y\??[?]?[?[??Y[??[????\??[???X????\?[?[??X?[???X?X^HXY??\?\?]?H]\?[?][?[?]?[?X[?Z[\?K?]Y\???\?XX?]]X?[?[??\?H?[?\?XX?]]X?[??\[?H???\?Y?H?X]Y[??]Y[???]?\?[?\?Y??X?[]??X]]]?[[][?H[?[??[[X]?H\??\??S???S??T?T?TH?P?RU?T?T?US???[?Y?[[??X?????K[?? ?? KH?]?]K?[Z[K[??Y??\[?H[?X?]?H[?H?Y[?\YY?\?[\??[???H?\?X\??\??X?Z]?YH?^HT?][? K??K?X??[]\??Y]????[?X?][??H???\??[??[???[??\??]^?\??HSS PS??\?[??[?K?HS??\?[??[?H\?[?[\?][??Y?X?[?H??X[?[?H?[Y[?\\?X?[\?XH?[?\?H S?H]\??Y??^HH?]X?[??H[?H??????YH??\?X[?[[???[??\?? ?????H[?\??Y[??[??[?H]?[?Y[???]?\?[??Z\?[???]?\??]Y?[??\?\?\]]X??8?'??\?]ZY]H\??YY[?Y??\??]?H?\?X\??Y?[?H?\?H\?X?YH?[?\??[?H[?\?Z[??YX?[?\?\??\?X\?H???\??[??][?[?[??H???\???[??\???H?Y?\???\?H[?\??H[??\??\??Y\??8?'H?ZYZX?Y[???X????\?Y[?[??S?????8?'?H]?H\??[X?Y??X?\????Y[?\??]X?[??\?[\?[??[?[???X]X???\X?[]Y\?[??\?[???\??\??[???]?[?YH??\?\??\?X\??[?]?[?Y[?[??H?[??[ZX?[X?\??][??][?\?YH\?X\?H[?H??\[?[?XY???X??[?\?\Y\????X?]]??'H??\??]?[?\?H?Y[?\??YY][????\?[??Y]????]X?[??HSS PS??\?[??X?\??Y[??\?Y[?H?X??]?]Y[???]??X\????[???\?X[?[[???[??\? ????K??????\?H?Z[?[?T??][???SS PS?[?????]?[?????H?\?X\????Y?XY???\?[?\?\K????\??H?????\?][?\[?[?H\???\?Y]?\?H[??Y[???\??[??X\???Z[??X\??[??[Y[???HS??[?H]?\?[[?H]???X?^?\??[??H?\?[???Z[?[????[[?HSS PS???\?[?\]YH[?H[?\??H\?]??\?X\??Y?[?H\???\][H?[?Y?[?Y??]?][H[[???Y[?\?Y??]?\?Y?\??]\???[[?H?Y?\?Y\?HY?\?]X[]H[?X??H???[???[Y\??X[H]?Z[X?KH?\??X??H??\[?I???\?X\????\?\?]?\?X\?H?\?X\??Y?[?K?H??\[?H?Y?[\?H?\?\?H?\?[??]??[?[????]H?\?X\????[][?]H?XHY?[\X???\??[X?X?][?? ?[?]\?H?[?X?????H][?H[?]????[??Y\??X??][???]X?Y[ZXH[?[?\??K???\???Y??H\??8?'?H?H[??[Y?[?^[\\???[??][?[?\?X\??[?\???[^?YYYX?[?H]H]?H?Y[??H\???\?H??[?????HH]Y[??HX?[??X???]Y[??[?][?H?X?H???YX\??8?'HX???[???X\?H[?\?T??[???Q[?[?\?X?HX??]HS???H[??[??\??P?K?[???[??\?\?H?? ??XY[???]\?H??[??\?X]?]Y[??\?H\?X[HXY???Y?]Y?[??Y\?X\?H[?]?HH?\?H???\??]?[?]K??X?[?H?^?\???[??H ?^??[?X?H?\?\??Y[?HT????X]Y[?]\??]?]Y[???]HS??\?[?[??]?\?[??\[?Y\?]?HY][?[\?\]]X??[??\?[?\??[?X?[?X[?Y?\??[?Y?[[??X?????H ?? H\?H?]?]K?[Z[K[??Y??\[?H[?X?]?H[?H?Y[?\YY?\?[\??[???H?\?X\??\?X?[\?H\?]?[]\???[??\???[?\??[??H[\?[??H?\?[??[?X??Y\??]Y?]?[???X?Y?X?]H[??]?[????\?[??K??????HPV?QHT?PH?RQHHHLH]Y?\??L? H]Y?\???

The mazda pharma Guide 5th August to 11th August 2013 | Page 68