Wave Of Molnupiravir Generics In India Amid Early Physician Cheer
India authorizes molnupiravir for restricted emergency use in COVID-19, marking the arrival of around a dozen “affordable” generics of Merck & Co. and Ridgeback Biotherapeutics' oral antiviral. Physicians say data are “pretty compelling” notwithstanding the narrow FDA nod.
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Torrent expects US FDA’s final approval for Allergan/Almirall’s Aczone, a dapsone formulation for acne vulgaris, in February, even as it awaits regulatory clearance for manufacturing sites. Meanwhile, it has launched molnupiravir in India and is hiking its domestic sales force by 400-500.
More generic deals but also US approval hurdles for Merck's oral antiviral, while Japan approves more options and Valneva's vaccine candidate shows promise against Omicron.
Merck and Lilly tackle some early challenges before striking voluntary licensing deals for COVID-19 therapies with Indian firms. Data around the use of these drugs in low- and middle-income countries could also potentially make them ‘more acceptable’ elsewhere, experts say.