Abacavir hydroxyacetate

Lupin has been granted tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Abacavir, Dolutegravir, and Lamivudine Tablets for Oral Suspension, 60 mg/5 mg/30 mg, to market a generic equivalent of Triumeq PD® Tablets for Oral Suspension, of ViiV Healthcare Company. This product would be manufactured at Lupin’s Nagpur facility in India. The fixed-dose combination of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen indicated for the treatment of HIV-1 infection in pediatric patients aged at least 3 months and weighing at least 6 kg. Abacavir, Dolutegravir, and Lamivudine Tablets for Oral Suspension, 60 mg/5 mg/30 mg, (RLD Triumeq PD) had an estimated annual sale of USD 1.3 million in the US. Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the US across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals.

The National Pharmaceutical Pricing Authority (NPPA) has asked drug manufacturers and marketers to furnish the information relating to price to retailer (PTR) and moving annual turnover (MAT) in value term for about 29 NLEM formulations for the month of March 2021. The information will be used by NPPA for fixing ceiling price of the formulations under provisions of DPCO, 2013. The formulations include abacavir (60mg tablet), acetylsalicylic acid (effervescent/dispersible/enteric coated 300 mg to 500 mg tablet), acetylsalicylic acid (300 mg to 500 mg tablet), activated charcoal (powder as licensed), calcium carbonate (250 mg tablet), calcium folinate (3mg/ml injection), cloxacillin (125 mg/5 ml oral liquid), cycloserine (125 mg capsule), dapsone (50 mg tablet) and doxycycline (50 mg/ 5 ml dry syrup). The other formulations are ethionamide (125 mg tablet), ferrous salt (A) + folic acid (B) (20 mg elemental iron (A) + 100 mcg oral liquid), ferrous salts (tablet equivalent to 60 mg of elemental iron), hydroxocobalamin (1 mg/ml injection), iohexol (140 to 350 mg iodine/ml injection), lamivudine (A)+ zidovudine (B) ((30 mg (A)+60 mg (B) tablet), medroxyprogesterone acetate (5 mg tablet), methylthioninium chloride (methylene blue) (10 mg/ml injection), miltefosine (50 mg capsule) and nevirapine (50 mg dispersible tablet). Besides them, the list of formulations which will be placed under price control include nystatin (100,000 IU pessary) & nystatin (100,000 IU/ml oral liquid), paromomycin (375 mg/ml injection), povidone iodine (5 per cent drops), pyridoxine (50 mg tablet), sodium chloride (3 per cent injection), vitamin A (100000 IU/ml oral liquid) zidovudine (50 mg/ 5 ml oral liquid) and zidovudine (A)+ lamivudine (B)+ nevirapine (C) ((60 mg (A) + 30 mg (B) + 50 mg (C) tablet). Earlier NPPA had withdrawn ferrous salt (A) + folic acid (B) (20 mg elemental iron (A) + 100 mcg oral liquid) formulation from price control order. Rashmi Tahiliani, joint director (pricing), NPPA issued an office memorandum in this regard on July 9, 2021. Tahiliani asked the drug manufacturers and marketing firms to furnish the information pertaining to the formulations, their dosage form and strength, brand, pack size, MAT and PTR as on March 2021 in a prescribed format within ten days from the issue of this memorandum. The NPPA has also directed pharmaceutical organizations-- OPPI, IDMA, AISSPMA, FICCI, IPA and FOPE to ask their member companies to furnish the said information to it.