Generics/News
European approval for fluticasone/salmeterol and gefitinib generics
Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced on 10 September 2018 that its subsidiary Glenmark Arzneimittel had secured marketing authorization in Germany for its generic fluticasone/salmeterol dry powder inhaler (DPI).
FDA approves first EpiPen generic amid shortages
The US Food and Drug Administration (FDA) announced on 16 August 2018 that it had approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and paediatric patients.
Australia approves first capsule-form Viagra generic
Singapore-based iX Biopharma announced on 6 August 2018 that it had received approval from Australia’s Therapeutic Goods Administration (TGA) for its sildenafil drug, which is delivered in an oral capsule for treating erectile dysfunction.
Generic diabetes and cancer drugs pose challenge to Bristol-Myers Squibb and Eli Lilly
Generics manufacturers in Bangladesh and Germany have recently announced the launch of generic versions of Bristol-Myers Squibb’s diabetes treatment Glucophage and Eli Lilly’s lung cancer drug Pemetrexed.
Ulcerative colitis and diabetes generics launched in US
Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 9 July 2018 that it had launched generic budesonide extended-release tablets (9 mg) in the US. Then on 25 July 2018, Sun Pharmaceutical Industries (Sun Pharma), one of India’s largest pharmaceutical manufacturers, announced that it had launched generic metformin extended-release tablets (500 and 1,000 mg) in the US.
Generic cancer pain relief launched in Japan
Japan-based Daiichi Sankyo announced on 15 June 2018 that it had launched a generic version of cancer pain relief Fentos Tape (fentanyl citrate tape).
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.
