Generics/News
Gilead to license hepatitis C drug to Indian generics firms
Gilead Sciences (Gilead) has announced plans to license its breakthrough hepatitis C drug Sovaldi (sofosbuvir) to at least three Indian generics manufacturers. The announcement made in February 2014, comes three months after the company faced a ‘patent opposition’ filed at India’s Patent Office, which aimed to block them from gaining a patent for Sovaldi in India.
Sandoz gains Belgian approval for generic inhalation device
In an example of the innovative nature of generics manufacturers, Sandoz, the generics unit of Swiss pharma giant Novartis, announced on 12 February 2014 that it had received marketing authorization in Belgium for AirFluSal Forspiro, an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD).
Forest Labs files lawsuit to stop generic memantine
Forest Laboratories and Forest Laboratories Holdings (Forest) announced on 31 January 2014 that the company has filed a lawsuit in the US against several generics makers for their generic versions of Forest’s blockbuster Alzheimer’s disease treatment Namenda XR (memantine).
FDA issues Ranbaxy with Form 483 for violations at Toansa plant
Ranbaxy Pharmaceuticals (Ranbaxy) is coming under scrutiny from US Food and Drug Administration (FDA) once again. One of the company’s key Indian facilities at Toansa, Punjab, has been issued a Form 483 by FDA.
ANI Pharmaceuticals acquires 31 generics from Teva
US-based brand-name and generics manufacturer ANI Pharmaceuticals (ANI) announced on 26 December 2013 that it had acquired 31 previously marketed generic drugs from Teva Pharmaceutical Industries (Teva).
Sandoz gains Danish approval for innovative asthma inhaler
Sandoz, the generics unit of Swiss pharma giant Novartis, announced on 18 December 2013 that it had received Danish marketing authorization for AirFluSal Forspiro, a novel inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD).
First generics of Cymbalta approved by FDA
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.
Sandoz makes deal with Shire for authorized Adderall XR generic
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.
Hikma makes deal to enhance delivery of generic injectables
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.
FDA approves first rabeprazole generics for treatment of GERD
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).
