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Generics/News

Duloxetine V14A10

First generics of Cymbalta approved by FDA

Generics/News | Posted 10/01/2014

The US Food and Drug Administration (FDA) announced on 11 December 2013 that it had approved the first generic versions of duloxetine delayed-release capsules, a prescription medicine used to treat depression and other conditions.

Amphetamine V13L13

Sandoz makes deal with Shire for authorized Adderall XR generic

Generics/News | Posted 13/12/2013

Shire announced on 2 December 2013 that its subsidiary Shire US had entered into an agreement to supply an authorized generic version of its attention deficit hyperactivity disorder (ADHD) drug Adderall XR (amphetamine, dextroamphetamine mixed salts) to Sandoz.

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Hikma makes deal to enhance delivery of generic injectables

Generics/News | Posted 06/12/2013

Hikma Pharmaceuticals (Hikma) announced on 20 November 2013 that it had signed a long-term commercial supply contract with Unilife Corporation (Unilife) for the use of Unifill pre-filled syringes with a range of generic injectable drugs.

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FDA approves first rabeprazole generics for treatment of GERD

Generics/News | Posted 29/11/2013

On 8 November 2013, the US Food and Drug Administration (FDA) announced that the agency had approved the first generics of Aciphex (rabeprazole) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).

Generics Blue Cap V13C15

First generic 30 mg Focalin XR capsules approved

Generics/News | Posted 22/11/2013

On 18 November 2013, Mylan Pharmaceuticals announced the launch of generic dexmethylphenidate hydrochloride extended-release (ER) capsules, 30 mg.

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Ranbaxy sues Actavis over generic acne drug

Generics/News | Posted 15/11/2013

Indian generics giant Ranbaxy Laboratories (Ranbaxy) is suing US generic drugmaker Actavis to try to stop the latter marketing a generic version of Ranbaxy’s acne drug Absorica (isotretinoin).

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Good news for Ranbaxy plant in US

Generics/News | Posted 08/11/2013

Ranbaxy Laboratory’s (Ranbaxy) US-based plant, Ohm Laboratories (Ohm), has successfully passed an FDA inspection, according to an announcement on the generic drugmaker’s website.

Tobramycin V13J31

FDA approves generic tobramycin inhalation solution

Generics/News | Posted 31/10/2013

Teva Pharmaceutical Industries (Teva) announced on 14 October 2013 that the US Food and Drug Administration (FDA) had granted approval for its abbreviated new drug application (ANDA) for tobramycin inhalation solution.

Inhaler MD002004 V13J25

Making generics of Advair could be difficult

Generics/News | Posted 25/10/2013

GlaxoSmithKline’s (GSK) fears of generics competition for its chronic obstructive pulmonary disorder treatment Advair (fluticasone/salmeterol) may be unfounded according to generics manufacturer Teva Pharmaceutical Industries (Teva).