Menu

Generics/News

26 AA011066

Chinese company makes copy of patented coronavirus treatment remdesivir

Generics/News | Posted 28/02/2020

China’s BrightGene has successfully produced remdesivir, an experimental treatment for coronavirus, however, patents for the drug are currently held by the American company Gilead.

80 MD002386

EMA recommends four new generics

Generics/News | Posted 21/02/2020

At the Committee for Medicinal Products for Human Use’s (CHMP) January 2020 meeting, the Committee recommended four new generics, and one new biosimilar, for approval.

X-ray1 MD001877 V13E03

FDA approves generics for cancer and gout

Generics/News | Posted 31/01/2020

The US Food and Drug Administration (FDA) has approved two generic versions of Novartis’ anticancer drug Afinitor (everolimus), alongside a generic of Takeda’s gout treatment Uloric (febuxostat).

MS Nerve Cells V13C03

FDA approves MS and prostate generics

Generics/News | Posted 17/01/2020

The US Food and Drug Administration (FDA) in December 2019 approved the first generics of Gilenya (fingolimod) for multiple sclerosis (MS) and Rapaflo (silodosin) for benign prostatic hyperplasia.

10 AA008993

EMA recommends approval for two new generics

Generics/News | Posted 06/12/2019

The European Medicines Agency’s (EMA) human medicines committee recommended seven new medicines for approval at its November 2019 meeting, including two generics: clopidogrel/acetylsalicylic acid and deferasirox.

49 MD002204

Dubai’s LIFEPharma signs historic agreement with Canada’s Apotex

Generics/News | Posted 22/11/2019

LIFEPharma, a wholly-owned subsidiary of the United Arab Emirates (UAE)-headquartered VPS Healthcare, has announced a historic agreement with Apotex Inc, Canada’s largest producer of generic drugs.

Multiple Sclerosis V14A24

Glenmark and Lupin gain FDA approval for nervous system agents

Generics/News | Posted 08/11/2019

Indian generics maker Glenmark Pharmaceuticals has been granted tentative US Food and Drug Administration (FDA) approval for its multiple sclerosis (MS) generic, while generics giant Lupin Ltd has also received FDA approval for its Dilantin generic, an anti-seizure medication.

AB004665

Alimta and Orfadin generics approved by FDA

Generics/News | Posted 11/10/2019

The US Food and Drug Administration (FDA) has tentatively approved Mylan’s pemetrexed, a generic version of Eli Lilly’s cancer drug Alimta, and approved Novitium Pharma’s generic equivalent of Swedish Orphan Biovitrum's Orfadin (nitisinone capsules).

AB004665

EMA approves leukaemia and multiple myeloma generics

Generics/News | Posted 27/09/2019

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 20 September 2019 that it had recommended granting marketing authorization for hypertension and leukaemia and multiple myeloma generics.

10 AA008993

FDA approves Farxiga generic

Generics/News | Posted 23/08/2019

The US Food and Drug Administration (FDA) has given tentative approval to Novartis for their generic version of AstraZeneca’s diabetes medicine Farxiga (dapagliflozin). Patent issues, however, must be resolved before FDA grants full approval.

NBCD 1 V13J25

Certara technology achieves first FDA virtual bioequivalence approval for a complex generic drug

Generics/News | Posted 09/08/2019

On 12 June 2019, Certara announced that its Simcyp physiologically-based pharmacokinetic (PBPK) modelling and simulation technology successfully demonstrated the bioequivalence of a complex generic drug. This has led to US Food and Drug Administration (FDA) approval of the drug on the agency’s abbreviated new drug application (ANDA) pathway.

MD002152

EMA approves two generics for fungal infections

Generics/News | Posted 19/07/2019

On 29 May 2019, the European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for two new generics for the treatment and prevention of fungal infections, Posaconazole Accord and Posaconazole AHCL.

25 AA011049

FDA approval for Unichem Lab’s hydrochloride medicines and Teva’s nasal spray to treat opioid overdose

Generics/News | Posted 21/06/2019

The US Food and Drug Administration (FDA) has granted Unichem Laboratories a tentative abbreviated new drug approval (ANDA) for their generic hydrochloride tablets, and has approved the first generic naloxone hydrochloride nasal spray, manufactured by Teva Pharmaceuticals (Teva).

31 MD000575

Teva launches generic testosterone gel and overactive bladder treatment in the US

Generics/News | Posted 31/05/2019

In April 2019, Israeli generics giant Teva Pharmaceutical Industries (Teva) announced the launch of generic versions of AndroGel (testosterone gel) 1.62% CIII and VESIcare (solifenacin succinate) tablets, 5 mg and 10 mg, in the US.

151 MD002298

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.

88 MD002468

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.

80 MD002386

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.

Inhaler MD002004 V13J25

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.

52 MD002433

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.

NBCD 2

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.