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FDA approves first Suboxone generics for opioid dependence

The US Food and Drug Administration (FDA) announced on 14 June 2018 that it had approved the first generics of Suboxone (buprenorphine/naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence. The generics have been developed by Indian generics maker Dr Reddy’s Laboratories (Dr Reddy’s) and US-based drugmaker Mylan.

US approval for prostate cancer formulation and impotence generics

The US Food and Drug Administration (FDA) has approved generics of tadalafil, used to treat male impotence, and a new abiraterone formulation, a treatment for prostate cancer.

Aurobindo and Lannett expand their generics portfolios

Both Indian generics maker Aurobindo Pharma (Aurobindo) and US generics company Lannett have announced efforts to increase their generics portfolios.

Price of leukaemia drug in Japan halved

Japanese drugmaker Ohara Pharmaceutical has reduced the price of its leukaemia generic imatinib to about half the price of the generics sold by its competitors to encourage leukaemia patients to use more affordable medication.

Hikma launches HIV generic ritonavir in the US

Jordan-based drugmaker Hikma Pharmaceuticals (Hikma) announced on 20 March 2018 that its wholly owned US subsidiary West-Ward Pharmaceuticals Corp had launched generic ritonavir tablets (100 mg) in the US.

Alvogen receives European approval for generic lenalidomide

US generics company Alvogen announced on 24 April 2018 that it had successfully concluded multiple registration procedures for its lenalidomide generic capsules.

Teva launches ulcerative colitis generic in the US

Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 26 March 2018 that it had launched generic mesalamine delayed-release tablets (1.2 g) in the US.

Australia’s Mayne Pharma launches generic antibiotic in US

Australia-based Mayne Pharma announced on 15 March 2018 that it had launched a generic version of doxycycline monohydrate immediate release (IR) capsules (50, 75 and 100 mg) in the US.

GSK fined GBP 37.6 million in pay-for-delay appeal

GlaxoSmithKline (GSK) has lost its appeal over a pay-for-delay case dating back to the early 2000s and involving its now off-patent antidepressant Seroxat/Paxil (paroxetine).

Lupin launches generic memantine XR capsules in the US

India-based generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 21 February 2018 that it had launched a generic version of Allergan’s Alzheimer’s disease treatment Namenda XR (memantine XR).

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