FDA approved Generics from India for AIDS

FDA Drugs-AIDS

FDA approved Generics from India for AIDS

Table 1: FDA tentative approvals of generic ARVs

Date	Drug	Company
7 October 2008	3TC 150 & 300mg	Macleods, India
24 September 2008	ddI delayed release capsules (125, 200, 250 and 400 mg)	Aurobindo, India
19 September 2008	Retrovir syrup, capsules and tablets	Matrix, India
26 June 2008	AZT oral solution (50 mg/5 mL)	Cipla, India
19 June 2008	3TC/d4T 30mg/6mg & 60mg/12mg paediatric tablets and oral suspension	Cipla, India
25 May 2008	Nevirapine (200mg tabs)	Matrix, India
9 May 2008	FTC (emtricitabine)	Aurobindo, India
25 March 2008	AZT (300mg)	Hetero, India
25 March 2008	AZT+3TC (300/150mg)	Hetero, India
20 March 2008	d4T (30mg) + 3TC + nevirapine	Strides, India
20 March 2008	d4T (40mg) + 3TC + nevirapine	Strides, India
4 February 2008	Atazanavir (100, 150, 200mg)	Emcure, India
14 February 2008	AZT (300mg)	Matrix, India
29 February 2008	efavirenz (600mg)	Hetero, India
29 February 2008	d4T (15, 20, 30, 40mg)	Hetero, India
29 January 2008	3TC (300 & 150 mg)	Hetero, India
30 November 2007	Tenofovir DF (300mg)	Matrix, India
29 November 2007	AZT/3TC (300/150 mg)	Matrix, India
2 November 2007	d4T/3TC (40/150mg and 30/150mg)	Matrix, India
29 October 2007	d4T oral solution	Cipla, India
13 August, 2007	Pedimune (paediatric nevirapine/d4T/3TC)	Cipla, India
13 August, 2007	nevirapine tabs (200mg)	Hetero Drugs, India
8 August, 2007	AZT+3TC (300/150mg)	Emcure Pharma, India
12 July, 2007	efavirenz tabs (600mg)	Matrix Labs, India
10 July 2007	nevirapine tabs (200mg)	Zhejiang Huahai Pharma, China
23 May 2007	Zidovudine (AZT) 100mg caps	Cipla Laboratories, India
23 April 2007	d4T 30 and 40 mg caps	Matrix Labs, India
5 April 2007	abacavir, 300mg tabs	Matrix Labs, India
26 March 2007	efavirenz tablets (600 mg)	Strides Acrolab, India
19 March 2007	3TC (150mg)	Matrix Labs, India
13 March 2007	d4T/3TC (40mg/150mg) tablets	Strides Acrolab, India
13 March 2007	d4T/3TC (40mg/150mg) tabletswith NVP co-package	Strides Acrolab, India
2 Mach 2007	AZT/3TC FDC with NVP copackaged	Strides Arcolab, India
20 January 2007	3TC/d4T FDC tablets, (150mg/ 30mg or 150mg/40mg)	Cipla, India
19 December 2006	Efavirenz, 50, 100, 200 mg caps	Aurobindo, India
17 Nov 06	d4T/3TC/NVP (FDC)	Cipla, India
6 Nov 06	abacavir 300 mg	Cipla, India
5 Oct 06	ddI 10mg/mL oral solution (paediatric)	Aurobindo, India
13 Sep 06	3TC/AZT 150 mg/300 mg FDC	Cipla, India
23 Aug 06	3TC/AZT 150mg/300mg	Pharmacare, S Africa
28 Aug 06	stavudine capsules, 30mg & 40mg	Strides Acrolab Ltd
11 Aug 06	nevirapine 200mg	Strides Acrolab Ltd
26 July 06	3TC/AZT copackaged with abacavir	Aurobindo, India
10 July 06	ddI tablets, 100 mg	Aurobindo, India
June 22 06	Lamivudine - oral solution, 10 mg/mL	Cipla Ltd
June 27 06	Stavudine 15 and 20 mg capsules	Aurobindo Pharma, India
June 27 06	Abacavir Sulfate Oral Solution, 20 mg/mL	Aurobindo Pharma, India
June 27 06	3TC/AZT/nevirapine fixed dose combination	Aurobindo Pharma, India
May 18, 06	abacavir sulfate tablets, 300 mg	Aurobindo Pharma, India
March 27, 06	zidovudine 100mg capsules	Aurobindo Pharma, India.
March 6, 2006	copackaged AZT/3TC + efavirenz	Aurobindo Pharma, India.
December 27, 05	nevirapine oral suspension, 50 mg/5 mL	Aurobindo Pharma, India.
December 21, 05	stavudine oral solution, 1 mg/mL	Aurobindo Pharma, India.
November 4, 05	lamivudine oral solution, 10 mg/mL	Aurobindo Pharma, India.
September 7, 05	zidovudine oral solution	Aurobindo Pharma, India.
August 25, 05	zidovudine 300mg tablets	Aurobindo Pharma, India.
July 13, 05	zidovudine 300mg tablets	Ranbaxy Laboratories, India
July 7, 05	lamivudine + zidovudine FDC	Aurobindo Pharma, India.
July 1, 05	stavudine capsules	Aurobindo Pharma, India.
June 24 05	efavirenz	Aurobindo Pharma, India.
June 20, 05	nevirapine tablets	Ranbaxy Laboratories, India
June 20, 05	nevirapine tablets	Aurobindo Pharma, India.
June 15, 05	lamivudine tablets, 150 and 300 mg	Aurobindo Pharma India.
May 27, 05	lamivudine tablets, 150mg	Ranbaxy Laboratories, India
January 26 05	copackaged AZT/3TC + nevirapine	Aspen Pharmacare, South Africa.
December 3, 04	didanosine (ddI) ER capsules, 200, 250, 400mg	Barr Laboratories, USA
May 17, 04	FDA issue guidance document that describes the new process to expedite approval of low cost, safe and effective co-packaged and fixed dose combination (FDC) HIV therapies so that high quality drugs can be made available in Africa and developing countries around the world under the President’s Emergency Plan for AIDS Relief (PEPFAR).
Source for Table 1: individual FDA list serve posts http://www.fda.gov/oashi/aids/listserve/archive.html#index

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