New Delhi: Drug makers Natco Pharma and Hetero have got approval from the Drugs Controller General of India (DCGI) to sell generic version of Daclatasvir, used for treatment of chronic hepatitis C. In a BSE filing today, Natco Pharma said: “It is the first company in India to get approval for generic Daclatasvir Dihydrochloride (Daclatasvir) tablets, 30 mg & 60 mg, from the Drugs Controller General (India).”
“The company has received the approval from Drug Controller General of India (DCGI) for the generic version of Daclatasvir tablets in the strengths of 30mg and 60mg,” Hetero said in a statement.
Daclatasvir is the first-in-class NS5A inhibitor used in combination with Sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) genotype 3 infection. “Compared with other treatment options, this combination not only increases the cure rate, but is also regarded as a valuable treatment option in some of the difficult-to-treat HCV patient subsets,” Natco said adding that it will market generic Daclatasvir under its own brand ‘NATDAC’, and through its strategic partners in India.
Natco will launch immediately in India at Rs 6,000 and Rs 4,000 for the 60 mg and 30 mg strengths, respectively, for a bottle of 28 tablets. Hetero said its product is generic version of Bristol-Myers Squibb’s Daklinza tablets.
“The product in combination with Sofosbuvir is indicated for the treatment of Hepatitis C genotype 3 infections, which is highly prevalent in India,” Hetero added. Hetero has around 25 manufacturing facilities worldwide and its portfolio includes over 200 products in therapeutic categories such as HIV/AIDS, Cardiovascular, Oncology, Neurology and Hepatitis.