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FDA approves drug for cancers with specific biomarker

The US Food and Drug Administration (FDA) announced on 26 November 2018 that it had approved Vitrakvi (larotrectinib), a treatment for adult and paediatric patients whose cancers have a specific genetic feature (biomarker).

Glenmark gains FDA approval for MS and pneumonia generics

In November 2018, Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced the approval of generics for the treatment of multiple sclerosis (MS) and pneumonia.

Apotex having trouble with Competitive Generic Therapy exclusivity

In August 2018, the US Food and Drug Administration (FDA) approved its first drugs under the Competitive Generic Therapy (CGT) designation. The agency granted approval to several strengths of Canada-based Apotex’s potassium chloride oral solution (10% and 20%) [1]. Being the first to receive approval under the CGT designation meant that Apotex was eligible for a 180-day period of marketing exclusivity. However, the company is now having trouble with this exclusivity due to timing issues.

Generics companies winning the legal battle in the US

Litigation in the US is clearing the way for generics competitors to enter the market. The latest cases include Spring Pharmaceuticals suing Retrophin for blocking generics of kidney stone drug Thiola (tiopronin) and the invalidation of Johnson & Johnson’s (J&J) patent on its prostate cancer drug Zytiga (abiraterone acetate).

China approves first ambrisentan generic

China’s drug regulator, the China Food and Drug Administration (CFDA, 国家食品药品监督管理局 in simplified Chinese), has approved its first ambrisentan generic.

Teva launches generic tadalafil but delays launch of generic Suboxone

Teva Pharmaceutical Industries (Teva) announced in September 2018 that it was launching generic tadalafil but would be delaying the launch of its higher-dose Suboxone (buprenorphine/naloxone) generic.

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.

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