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EMA approves hypertension and Parkinson’s generics

Generics/News | Posted 17/05/2019

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 26 April 2019 that it had recommended granting marketing authorization for hypertension and Parkinson’s generics.

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Stada launches generic Exforge following patent revocation

Generics/News | Posted 19/04/2019

German generics producer Stada Arzneimittel announced on 20 March 2019 that it is set to launch a generic version of the antihypertensive Exforge (amlodipine/valsartan combination), following the revocation of a Novartis European patent.

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FDA approves generics from Amneal and Dr Reddy’s, and Natco submits ANDA

Generics/News | Posted 22/03/2019

In January 2019, the US Food and Drug Administration (FDA) approved Amneal Pharmaceutical’s (Amneal) generic Exelon patch and Dr Reddy’s Laboratories (Dr Reddy’s) Tosymra nasal spray, and Natco Pharma submitted an abbreviated new drug application (ANDA) to FDA for its Ibrutinab tablets.

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Mylan launches Advair generic at 70% discount

Generics/News | Posted 01/03/2019

US-based drugmaker Mylan announced on 12 February 2019 the launch of Wixela Inhub (fluticasone/salmeterol inhalation powder, USP) at a list price 70% less than the originator product, GlaxoSmithKline’s (GSK) best-selling asthma drug Advair Diskus.

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Zydus gets FDA approval for skin, heart and acid reflux generics

Generics/News | Posted 15/02/2019

Zydus Cadila has received final approval from the US Food and Drug Administration (FDA) to market betamethasone dipropionate cream, 0.05%, a generic version of Diprolene® AF, and generic amlodipine and atorvastatin tablets (Caduet®). It has also received tentative FDA approval to market generic esomeprazole magnesium delayed-release capsules (Nexium®). This brings the total approvals of the Zydus group to 247, and it has so far filed over 330 abbreviated new drug applications (ANDAs) since the filing process commenced in the 2003‒2004 financial year.

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FDA approves Lupin’s generic clobazam and Dr Reddy's launches follow-on sevelamer carbonate

Generics/News | Posted 08/02/2019

By end of 2018, Lupin Pharmaceuticals Inc received US Food and Drug Administration (FDA) approval for its clobazam oral suspension, 2.5 mg/mL, and Dr Reddy's Laboratories Ltd (Dr Reddy) launched its sevelamer carbonate for oral suspension.

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Teva receives FDA approval for Sabril and launches Elidel cream

Generics/News | Posted 01/02/2019

In January 2019, Teva Pharmaceutical Industries (Teva) received US Food and Drug Administration (FDA) approval for its first generic version of Sabril (vigabatrin) and launched a generic version of Elidel (pimecrolimus) cream, 1%, in the US.

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Sun Pharma gets FDA approval for ganirelix acetate and plans to acquire Japan’s Pola Pharma

Generics/News | Posted 25/01/2019

Sun Pharmaceutical Industries (Sun Pharma), one of India’s largest pharmaceutical company, marks the start of 2019 with two exciting new developments.

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Dr Reddy’s launches omeprazole and continues sales of generic Suboxone in the US

Generics/News | Posted 18/01/2019

India-based generics manufacturer Dr Reddy’s is set to have a busy 2019 with the recent launch of generic omeprazole delayed-release tablets for the treatment of heartburn, and the lifting of a US injunction on its anti-narcotic addiction generic Suboxone (buprenorphine and naloxone).

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Sandoz to launch epinephrine in early 2019 at a discount to Mylan and Teva’s generics

Generics/News | Posted 11/01/2019

Sandoz, the generics division of Novartis, will launch Adamis Pharmaceuticals Corp’s EpiPen (epinephrine) generic Symjepi in early 2019. Symjepi received US Food and Drug Administration (FDA) approval of its 0.3 mg pre-filled single dose syringe in June 2017 [1], and for its lower dose version (0.15 mg) in September 2018. Epinephrine injectors are used for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise or unknown triggers. These can include reactions to insect bites or stings, foods, medications, latex or other causes.

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FDA approves drug for cancers with specific biomarker

Generics/News | Posted 14/12/2018

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).

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Glenmark gains FDA approval for MS and pneumonia generics

Generics/News | Posted 07/12/2018

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

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Apotex having trouble with Competitive Generic Therapy exclusivity

Generics/News | Posted 23/11/2018

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.

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Generics companies winning the legal battle in the US

Generics/News | Posted 16/11/2018

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).

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China approves first ambrisentan generic

Generics/News | Posted 26/10/2018

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.

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Teva launches generic tadalafil but delays launch of generic Suboxone

Generics/News | Posted 19/10/2018

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.

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European approval for fluticasone/salmeterol and gefitinib generics

Generics/News | Posted 12/10/2018

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).

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FDA approves first EpiPen generic amid shortages

Generics/News | Posted 28/09/2018

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.