Lupin gets EU approval for own muscle disorder drug

Lupin said the European Commission (EC) has approved mexiletine for the symptomatic treatment of nondystrophic myotonic (NDM) disorders in adults. Non-dystrophic myotonic disorders are a group of rare, inherited neuromuscular disorders which cause the inability to relax muscles following voluntary contraction. Lupin’s NaMuscla reduces myotonia...

Alembic Pharmaceuticals gets USFDA nod for eye drug

Alembic Pharmaceuticals Ltd today announced that the company has received approval from the US Food & Drug Administration (USFDA) to sell a generic alternative to Novartis Pharmaceuticals’ allergic conjunctivitis treatment Patanol Ophthalmic Solution. This is first ophthalmic dosage form approval for Alembic pharmaceuticals Limited. The...

Alembic gets USFDA approval for generic heart drug

Alembic Pharmaceuticals said it has received approval from the US Food & Drug Administration (USFDA) to sell a generic version of ANI Pharmaceuticals’ hypertension drug Atacand Tablets. Atacand had an estimated market size of US$ 22 million for twelve months ending December 2017 in the US...

Lupin gets USFDA nod for asthma inhaler drug

Indian pharmaceutical manufacturer Lupin said it received regulatory approval to launch a generic version of AstraZeneca’s asthma inhalation medicine. Budesonide Inhalation Suspension is among medium-sized drugs sold in the United States, with annual sales of around $475 million. It is sold by AstraZeneca under the name...

Lupin launches pneumonia drug Atovaquone in the US

Pharma major Lupin said it has launched pneumonia suspension Atovaquone, a generic substitute for Glaxosmithkline’s Mepron oral suspension. The drug, in the dosage of 750 mg per 5 milliliter, had annual sales of approximately USD 119 million in the US. It is indicated for the prevention...

Dr Reddy’s sells Jeedimetla API plant to Therapiva

Dr. Reddy’s Laboratories, one of the biggest pharmaceutical companies in India, said it has agreed to sell its API manufacturing unit located in Jeedimetla, Hyderabad, to Therapiva Private Ltd, an emerging generics pharmaceutical company. The company did not reveal the financial details of the deal,...

Aurobindo wins South African approval for HIV drug

Aurobindo Pharma said it received approval from the South African authorities to launch a key anti-HIV drug in the country, following the launch of the medicine in Sub-Saharan Africa. Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (DLT) tablets are the  first-line, preferred regimen for HIV patients...

Lupin gets US FDA nod for pneumonia drug

Pharmaceuticals manufacturer Lupin said it has received US authorities’ approval to sell pneumonia medicine Atovaquone suspension. The drug had sales of approximately USD 117.4 million per year in the US. The 750 mg/5 mL oral solution is the generic version of GlaxoSmithKline’s Mepron Oral Suspension....