The company has received tentative approval from the US Food and Drug Administration to market Pimavanserin tablets in strength of 10 mg, Zydus Cadila said in a statement.
ZyCov-D, which is the first COVID-19 vaccine to be cleared by India's drug regulator for those aged 12 years and above, will only be administered to adults in the seven states as of now, sources said.
The company has received final approval from the US Food and Drug Administration (USFDA) to Decitabine for Injection in the strength of 50 mg/vial single-dose vial, Zydus Cadila said in a statement.
The health ministry has given a go ahead to initiate the preparatory work for the inclusion of the indigenously-developed, needle-free jab in the national Covid inoculation drive and it can be introduced in the programme anytime soon.
The Ahmedabad-based pharma company earlier had proposed a price of Rs 1,900 for its three-dose regimen, a source had said.
The RNA-based vaccine, meant for the age group of 12 to 18 besides adults, got the Emergency Use Authorisation from the drug regulator on August 20.
Pharma company Zydus Cadila is learnt to have proposed a price of Rs 1,900 for its three-dose jab ZyCov-D that can be given to those above 12 years of age.
The government had on Thursday said that the indigenously-developed, world's first DNA-based needle-free COVID-19 vaccine by Zydus Cadila will be introduced in the nationwide anti-coronavirus vaccination drive shortly.
"The call of the hour is to give the two-dose vaccination/full vaccination covering the entire adult population. The talk of booster dose is not pertinent at the moment," said ICMR DG Dr. Balram Bhargava.
Zydus Cadila's coronavirus vaccine ZyCoV-D is likely to be launched in early October, according to sources.
The NDA received tentative approval upon completion of the first review cycle on September 2, 2021, Zydus Cadila stated.
The company's indigenously developed needle-free three-dose COVID-19 vaccine ZyCoV-D was granted emergency use authorisation (EUA) by the drug regulator on Friday, making it the first vaccine to be administered to beneficiaries in the age group of 12-18 years in the country.
Zydus Group MD Dr. Sharvil Patel has claimed that 'ZyCoV-D' vaccine holds about 66% efficacy against the Delta variant of COVID-19.
ZyCoV-D vaccine: Zydus Cadila's 3-dose vaccine 'ZyCoV-D' has finally got approval for emergency use by India's central drug authority. The vaccine is the world's first and India's indigenously developed DNA-based vaccine for Covid-19.
The Drugs Controller General of India (DCGI) on Friday gave approval for emergency-use authorization of Zydus Cadila's ZyCoV-D vaccine, the Union Ministry of Science and Technology said.
An expert panel of India's central drug authority has recommended granting emergency use authorisation to Zydus Cadila's three-dose COVID-19 vaccine ZyCoV-D, sources said.
Zydus Cadila's needle-free COVID-19 vaccine 'ZyCoV-D' will be the sixth Covid vaccine to be available in India.
Zydus Cadila seeks Emergency Use Authorisation for its DNA vaccine, ZyCoV-D, for 12 years and above in India.
Zydus Cadila has concluded its clinical trials for the 12 to 18 age group, and the vaccine may be available in near future, subject to the statutory permissions.
Zydus said that its biological therapy ZRC-3308, a cocktail of two SARS-CoV-2-neutralising monoclonal antibodies (mAbs) can emerge as one of the main treatments for mild COVID-19.